KFF · Class II · 21 CFR 864.7525

FDA Product Code KFF: Assay, Heparin

Leading manufacturers include American Bioproducts Co., Instrumentation Laboratory CO and E.I. Dupont DE Nemours & Co., Inc..

47
Total
47
Cleared
206d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 244d recently vs 206d historically

FDA 510(k) Cleared Assay, Heparin Devices (Product Code KFF)

47 devices
1–24 of 47
Cleared Sep 24, 2026
STA® - Liquid Anti-Xa
K260214
Diagnostica Stago, Inc.
Hematology · 244d
Cleared Oct 04, 2022
HemosIL Liquid Anti-Xa
K213464
Instrumentation Laboratory CO
Hematology · 341d
Cleared Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
K162540
Siemens Healthcare Diagnostics Prodcts GmbH
Hematology · 344d
Cleared Oct 26, 2011
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
K111822
Diagnostica Stago, Inc.
Hematology · 120d
Cleared Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209
Instrumentation Laboratory CO
Hematology · 125d
Cleared May 24, 2006
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
K050367
Hyphen Biomed
Hematology · 464d
Cleared Aug 23, 2002
ENOXAPARIN TEST CARD
K013305
Cardiovascular Diagnostics, Inc.
Hematology · 323d
Cleared Apr 16, 2002
ACTICHROME HEPARIN (ANTI-FIIA)
K013637
American Diagnostica, Inc.
Hematology · 162d
Cleared Mar 08, 2002
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
K013318
American Diagnostica, Inc.
Hematology · 154d
Cleared Jun 07, 2001
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
K010455
Diagnostica-Stago
Hematology · 129d
Cleared Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193
International Technidyne Corp.
Hematology · 135d
Cleared Nov 03, 1998
COAMATIC HEPARIN
K983178
Instrumentation Laboratory CO
Hematology · 53d
Cleared Mar 19, 1998
IL TEST HEPARIN
K980242
Instrumentation Laboratory CO
Hematology · 55d
Cleared Aug 12, 1997
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209
Medical Diagnostic Technologies, Inc.
Hematology · 62d
Cleared Mar 18, 1997
MDA HEPARIN ANTI-X ASSAY
K965076
Organon Teknika Corp.
Hematology · 89d
Cleared Feb 14, 1996
CHROM Z-HEPARIN, CAT. NO 5242
K952667
Helena Laboratories
Hematology · 247d
Cleared Nov 20, 1995
COACUTE HEPARIN
K952514
Chromogenix AB
Hematology · 173d
Cleared Sep 26, 1995
THE HEPANORM HBPM/LMWH KIT
K943514
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
HBPM/LMWH CONTROL KIT
K943519
American Bioproducts Co.
Hematology · 432d
Cleared Sep 26, 1995
HEPARIN CONTROL KIT
K943520
American Bioproducts Co.
Hematology · 432d
Cleared Aug 31, 1995
ROTACHROM HEPARIN TEST KIT
K943515
American Bioproducts Co.
Hematology · 406d
Cleared Aug 31, 1995
ROTACHROM HBPM/LMWH TEST KIT
K943516
American Bioproducts Co.
Hematology · 406d
Cleared May 23, 1995
THE STACHROM HEPARIN ASSAY KIT
K925433
American Bioproducts Co.
Hematology · 937d
Cleared May 11, 1995
STACLOT HEPARIN TEST KIT
K943517
American Bioproducts Co.
Hematology · 294d

About Product Code KFF - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code KFF since 1979, with 47 receiving FDA clearance (average review time: 206 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KFF Product Code

Recent submissions under KFF have taken an average of 244 days to reach a decision - up from 206 days historically. Manufacturers should account for longer review timelines in current project planning.

KFF devices are reviewed by the Hematology panel. Browse all Hematology devices →