510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903874Substantially Equivalent

Fibrinotest(tm) - Fibrinogen Assay

Haemachem, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903874 is the FDA 510(k) clearance record for FIBRINOTEST(TM) - FIBRINOGEN ASSAY, a class II device, cleared for Haemachem, Inc. on under FDA product code GIS (Test, Fibrinogen). FDA records list 4 510(k) clearances for Haemachem, Inc., from to . As of , FDA records show no recalls naming K903874.

Clearance record

Decision date
Received
(176 days to decision)
Product code
GIS Test, Fibrinogen
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Haemachem, Inc. 2335 S. Hanley Rd., St. Louis MO
Third party review
No

Clearances, product code GIS

Trailing 12 months

FDA records hold no clearances under product code GIS in the trailing twelve months.

FDA records show no clearances under product code GIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GIS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260