HEMOSIL SYNTHASIL— 510(k) K060688

Name: FDA 510(k) clearance K060688
Creator: U.S. Food and Drug Administration
Published: 2006-04-13

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K060688 for HEMOSIL SYNTHASIL, Substantially Equivalent on 2006-04-13. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2006-03-15
Decision date: 2006-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060688

K-number listed on FDA's recall record

Z-1095-2026 — The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.Class II·Ongoing·Instrumentation Laboratory·20251211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060688.

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