IL TEST PLASMINOGEN— 510(k) K981200

Name: FDA 510(k) clearance K981200
Creator: U.S. Food and Drug Administration
Published: 1998-05-26

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K981200 for IL TEST PLASMINOGEN, Substantially Equivalent on 1998-05-26. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1998-04-02
Decision date: 1998-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K981200

K-number listed on FDA's recall record

Z-0736-2016 — HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrateClass II·Terminated·Instrumentation Laboratory Co.·20151218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981200.

Data sourced from openFDA. This site is unofficial and independent of the FDA.