510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912876Substantially Equivalent

Fibrinostika Fbdp Microelisa System

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

K912876 is the FDA 510(k) clearance record for FIBRINOSTIKA FBDP MICROELISA SYSTEM, a class II device, cleared for Organon Teknika Corp. on under FDA product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K912876.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
510(k) summary
Summary
Third party review
No

Clearances, product code DAP

Trailing 12 months
1 clearance under product code DAP in the twelve months to November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DAP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260