KFF · Class II · 21 CFR 864.7525

FDA Product Code KFF: Assay, Heparin

Leading manufacturers include American Bioproducts Co., Instrumentation Laboratory CO and International Technidyne Corp..

47
Total
47
Cleared
206d
Avg days
1979
Since
47 devices
25–47 of 47
Cleared May 10, 1995
HEPARIN MANAGEMENT TEST CARD
K943283
Cardiovascular Diagnostics, Inc.
Hematology · 307d
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 Jan 27, 1994
SPECTROLYSE HEPARIN KIT
K923499
Biopool AB
Hematology · 561d
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 Nov 29, 1990
HEMOCHRON(R) HEPARIN RESPONSE TEST
K904003
Intensive Technology, Inc.
Hematology · 92d
Cleared Oct 22, 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841
Organon Teknika Corp.
Hematology · 62d
Cleared Jul 20, 1990
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
K901874
Kabi Diagnostica
Hematology · 85d
Cleared Mar 15, 1990
ORTHOKROME* HEPARIN
K900396
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Jan 10, 1989
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
K884590
Hemotec, Inc.
Hematology · 68d
Cleared Jan 05, 1987
IL TEST 97575-15, HEPARIN ASSAY
K864211
Instrumentation Laboratory CO
Hematology · 69d
Cleared Mar 03, 1986
HEPANORM CALIBRATION PLASMA SET
K854762
American Bioproducts Co.
Hematology · 96d
Cleared Nov 05, 1985
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
K853239
Haemachem, Inc.
Hematology · 96d
Cleared May 08, 1985
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486
Warner-Lambert Co.
Hematology · 90d
Cleared Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
K843201
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Nov 30, 1984
HEPARIN CALIBRATOR ACA
K843202
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 108d
Cleared Jun 11, 1984
HEPARINOMETER
K834024
Western Laboratories Corp.
Chemistry · 202d
Cleared Jan 30, 1984
COATEST HEPARIN
K833891
Kabivitrum, Inc.
Hematology · 82d
Cleared Sep 29, 1983
DIACROM * HEPARIN
K832373
Wellcome Diagnostics
Chemistry · 73d
Cleared Oct 02, 1981
CI-TROL HEPARIN CONTROLS, LOW/HIGH
K812424
American Dade
Hematology · 39d
Cleared Feb 15, 1979
HEPARIN ASSAY
K781479
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 171d