IL TEST FIBRINOGEN-C— 510(k) K931721

Name: FDA 510(k) clearance K931721
Creator: U.S. Food and Drug Administration
Published: 1993-08-13

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K931721 for IL TEST FIBRINOGEN-C, Substantially Equivalent on 1993-08-13. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1993-04-07
Decision date: 1993-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

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K970189 — FIF TM1997-05-21

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