FIBRINOTEST(TM) - FIBRINOGEN ASSAY— 510(k) K903874

Name: FDA 510(k) clearance K903874
Creator: U.S. Food and Drug Administration
Published: 1991-02-14

Substantially Equivalent

Haemachem, Inc.

FDA 510(k) clearance K903874 for FIBRINOTEST(TM) - FIBRINOGEN ASSAY, Substantially Equivalent on 1991-02-14. Applicant: Haemachem, Inc.. Device class: 2.

Clearance details

Applicant: Haemachem, Inc.
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1990-08-22
Decision date: 1991-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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