ACL TOP 700 LAS— 510(k) K091980

Name: FDA 510(k) clearance K091980
Creator: U.S. Food and Drug Administration
Published: 2009-09-22

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K091980 for ACL TOP 700 LAS, Substantially Equivalent on 2009-09-22. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GKP
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 2009-07-01
Decision date: 2009-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K091980

K-number listed on FDA's recall record

Z-2060-2014 — ACL TOP (Base), automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2061-2014 — ACL TOP 700, automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2062-2014 — ACL TOP CTS, automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2063-2014 — ACL TOP 700 LAS, automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2064-2014 — ACL TOP 500 CTS, automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2065-2014 — ACL TOP 700 CTS, automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2066-2014 — ACL TOP 300 CTS, automated coagulation laboratory instrument.Class II·Terminated·Instrumentation Laboratory Co.·20140603
Z-2244-2013 — ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2245-2013 — ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2246-2013 — ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2247-2013 — ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2248-2013 — ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2249-2013 — ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2250-2013 — ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.Class II·Terminated·Instrumentation Laboratory Co.·20130719
Z-2387-2012 — Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parametersClass II·Terminated·Instrumentation Laboratory Co.·20120803
Z-2388-2012 — Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parametersClass II·Terminated·Instrumentation Laboratory Co.·20120803
Z-2389-2012 — Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parametersClass II·Terminated·Instrumentation Laboratory Co.·20120803
Z-2390-2012 — Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parametersClass II·Terminated·Instrumentation Laboratory Co.·20120803
Z-2391-2012 — Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parametersClass II·Terminated·Instrumentation Laboratory Co.·20120803
Z-2392-2012 — Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parametersClass II·Terminated·Instrumentation Laboratory Co.·20120803

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091980.

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