510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903841Substantially Equivalent

Organon Teknida Chromostrae (Tm) Heparin Anti-Xa

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

K903841 is the FDA 510(k) clearance record for ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA, a class II device, cleared for Organon Teknika Corp. on under FDA product code KFF (Assay, Heparin). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K903841.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KFF Assay, Heparin
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
Third party review
No

Clearances, product code KFF

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