510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K900895Substantially Equivalent

Coag-a-Mate - Ra4

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900895 is the FDA 510(k) clearance record for COAG-A-MATE - RA4, a class II device, cleared for Organon Teknika Corp. on under FDA product code KQJ (System, Fibrinogen Determination). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K900895.

Clearance record

Decision date
Received
(48 days to decision)
Product code
KQJ System, Fibrinogen Determination
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
Third party review
No

Clearances, product code KQJ

Trailing 12 months

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

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