KFF · Class II · 21 CFR 864.7525

FDA Product Code KFF: Assay, Heparin

Leading manufacturers include American Bioproducts Co., Instrumentation Laboratory CO and Organon Teknika Corp..

46
Total
46
Cleared
206d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

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

46 devices
1–24 of 46
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 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 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
Cleared May 06, 1994
HEMOLAB HEPARICHROM ASSAY
K934274
Biomerieux Vitek, Inc.
Hematology · 248d
Cleared Feb 07, 1994
IL TEST HEPARIN (XA), PN 84699-15
K935212
Instrumentation Laboratory CO
Hematology · 101d
Cleared Jun 28, 1993
BERICHROM HEPARIN
K925200
Behring Diagnostics, Inc.
Hematology · 255d
Cleared May 10, 1991
HITT BY HEMOCHRON(R)
K910181
International Technidyne Corp.
Hematology · 114d
Cleared Apr 29, 1991
HEPARIN CONTROLS, HIGH AND LOW
K910741
Sigma Diagnostics, Inc.
Hematology · 67d
Cleared Oct 22, 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841
Organon Teknika Corp.
Hematology · 62d

About Product Code KFF - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code KFF since 1979, with 46 receiving FDA clearance (average review time: 206 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.