Atlas FDA

KFF

46 FDA 510(k) clearances · Product code

129 daysmedian time to decision
432 days90th percentile
46clearances measured

FDA profile

Official device name
Assay, Heparin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7525
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
HemosIL Liquid Anti-Xa (K213464)Instrumentation Laboratory CO2022-10-04
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls (K162540)Siemens Healthcare Diagnostics Prodcts GmbH2017-08-22
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH (K111822)Diagnostica Stago, Inc.2011-10-26
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (K090209)Instrumentation Laboratory CO2009-06-02
BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (K050367)Hyphen Biomed2006-05-24
ENOXAPARIN TEST CARD (K013305)Cardiovascular Diagnostics, Inc.2002-08-23
ACTICHROME HEPARIN (ANTI-FIIA) (K013637)American Diagnostica, Inc.2002-04-16
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (K013318)American Diagnostica, Inc.2002-03-08
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (K010455)Diagnostica-Stago2001-06-07
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (K010193)International Technidyne Corp.2001-06-06
COAMATIC HEPARIN (K983178)Instrumentation Laboratory CO1998-11-03
IL TEST HEPARIN (K980242)Instrumentation Laboratory CO1998-03-19
SPECTROLYSE HEPARIN (ANTI-IIA) (K972209)Medical Diagnostic Technologies, Inc.1997-08-12
MDA HEPARIN ANTI-X ASSAY (K965076)Organon Teknika Corp.1997-03-18
CHROM Z-HEPARIN, CAT. NO 5242 (K952667)Helena Laboratories1996-02-14
COACUTE HEPARIN (K952514)Chromogenix AB1995-11-20
HEPARIN CONTROL KIT (K943520)American Bioproducts Co.1995-09-26
THE HEPANORM HBPM/LMWH KIT (K943514)American Bioproducts Co.1995-09-26
HBPM/LMWH CONTROL KIT (K943519)American Bioproducts Co.1995-09-26
ROTACHROM HEPARIN TEST KIT (K943515)American Bioproducts Co.1995-08-31
ROTACHROM HBPM/LMWH TEST KIT (K943516)American Bioproducts Co.1995-08-31
THE STACHROM HEPARIN ASSAY KIT (K925433)American Bioproducts Co.1995-05-23
STACLOT HEPARIN TEST KIT (K943517)American Bioproducts Co.1995-05-11
HEPARIN MANAGEMENT TEST CARD; HMT CARD (K943283)Cardiovascular Diagnostics, Inc.1995-05-10
HEMOLAB HEPARICHROM ASSAY (K934274)Biomerieux Vitek, Inc.1994-05-06
IL TEST HEPARIN (XA), PN 84699-15 (K935212)Instrumentation Laboratory CO1994-02-07
SPECTROLYSE HEPARIN KIT (K923499)Biopool AB1994-01-27
BERICHROM HEPARIN (K925200)Behring Diagnostics, Inc.1993-06-28
HITT BY HEMOCHRON(R) (K910181)International Technidyne Corp.1991-05-10
HEPARIN CONTROLS, HIGH AND LOW (K910741)Sigma Diagnostics, Inc.1991-04-29
HEMOCHRON(R) HEPARIN RESPONSE TEST (K904003)Intensive Technology, Inc.1990-11-29
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA (K903841)Organon Teknika Corp.1990-10-22
COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY (K901874)Kabi Diagnostica1990-07-20
ORTHOKROME* HEPARIN (K900396)Ortho Diagnostic Systems, Inc.1990-03-15
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES (K884590)Hemotec, Inc.1989-01-10
IL TEST 97575-15, HEPARIN ASSAY (K864211)Instrumentation Laboratory CO1987-01-05
HEPANORM CALIBRATION PLASMA SET (K854762)American Bioproducts Co.1986-03-03
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY (K853239)Haemachem, Inc.1985-11-05
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY (K850486)Warner-Lambert Co.1985-05-08
HEPARIN CALIBRATOR ACA (K843202)E.I. Dupont DE Nemours & Co., Inc.1984-11-30
HEPARIN ACA ANALYTICAL TEST PACK (K843201)E.I. Dupont DE Nemours & Co., Inc.1984-11-30
HEPARINOMETER (K834024)Western Laboratories Corp.1984-06-11
COATEST HEPARIN (K833891)Kabivitrum, Inc.1984-01-30
DIACROM * HEPARIN (K832373)Wellcome Diagnostics1983-09-29
CI-TROL HEPARIN CONTROLS, LOW/HIGH (K812424)American Dade1981-10-02
HEPARIN ASSAY (K781479)Dade, Baxter Travenol Diagnostics, Inc.1979-02-15

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