510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901874Substantially Equivalent

Coatest Lmw Heparin/heparin Chromogenic Assay

Kabi Diagnostica, Danville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901874 is the FDA 510(k) clearance record for COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY, a class II device, cleared for Kabi Diagnostica on under FDA product code KFF (Assay, Heparin). FDA records list 2 510(k) clearances for Kabi Diagnostica, from to . As of , FDA records show no recalls naming K901874.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KFF Assay, Heparin
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Kabi Diagnostica P.O. Box 430, Danville CA
Third party review
No

Clearances, product code KFF

Trailing 12 months
1 clearance under product code KFF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KFF, 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 20261
October 20260