510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924892Substantially Equivalent

Fibrinostika(r) Fgdp Microelisa System

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

K924892 is the FDA 510(k) clearance record for FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM, a class II device, cleared for Organon Teknika Corp. on under FDA product code DAT (Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K924892.

Clearance record

Decision date
Received
(569 days to decision)
Product code
DAT Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 864.7340
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 DAT

Trailing 12 months

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

FDA records show no clearances under product code DAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DAT, 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