HEMOSIL FIBRINOGEN-C— 510(k) K073367

Name: FDA 510(k) clearance K073367
Creator: U.S. Food and Drug Administration
Published: 2007-12-27

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K073367 for HEMOSIL FIBRINOGEN-C, Substantially Equivalent on 2007-12-27. 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: 2007-11-30
Decision date: 2007-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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