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Assay, Heparin

FDA product code KFF · 47 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.7525
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-02-15 – 2026-09-24

KFF 2026-09-24

STA® - Liquid Anti-Xa

Applicant Diagnostica Stago, Inc.

K number K260214

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KFF 2022-10-04

HemosIL Liquid Anti-Xa

Applicant Instrumentation Laboratory CO

K number K213464

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KFF 2017-08-22

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

Applicant Siemens Healthcare Diagnostics Prodcts GmbH

K number K162540

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KFF 2011-10-26

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

Applicant Diagnostica Stago, Inc.

K number K111822

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KFF 2009-06-02

HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS

Applicant Instrumentation Laboratory CO

K number K090209

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KFF 2006-05-24

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

Applicant Hyphen Biomed

K number K050367

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KFF 2002-08-23

ENOXAPARIN TEST CARD

Applicant Cardiovascular Diagnostics, Inc.

K number K013305

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KFF 2002-04-16

ACTICHROME HEPARIN (ANTI-FIIA)

Applicant American Diagnostica, Inc.

K number K013637

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KFF 2002-03-08

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

Applicant American Diagnostica, Inc.

K number K013318

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KFF 2001-06-07

ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

Applicant Diagnostica-Stago

K number K010455

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KFF 2001-06-06

HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS

Applicant International Technidyne Corp.

K number K010193

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KFF 1998-11-03

COAMATIC HEPARIN

Applicant Instrumentation Laboratory CO

K number K983178

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KFF 1998-03-19

IL TEST HEPARIN

Applicant Instrumentation Laboratory CO

K number K980242

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KFF 1997-08-12

SPECTROLYSE HEPARIN (ANTI-IIA)

Applicant Medical Diagnostic Technologies, Inc.

K number K972209

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KFF 1997-03-18

MDA HEPARIN ANTI-X ASSAY

Applicant Organon Teknika Corp.

K number K965076

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KFF 1996-02-14

CHROM Z-HEPARIN, CAT. NO 5242

Applicant Helena Laboratories

K number K952667

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KFF 1995-11-20

COACUTE HEPARIN

Applicant Chromogenix AB

K number K952514

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KFF 1995-09-26

HEPARIN CONTROL KIT

Applicant American Bioproducts Co.

K number K943520

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KFF 1995-09-26

HBPM/LMWH CONTROL KIT

Applicant American Bioproducts Co.

K number K943519

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KFF 1995-09-26

THE HEPANORM HBPM/LMWH KIT

Applicant American Bioproducts Co.

K number K943514

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KFF 1995-08-31

ROTACHROM HBPM/LMWH TEST KIT

Applicant American Bioproducts Co.

K number K943516

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KFF 1995-08-31

ROTACHROM HEPARIN TEST KIT

Applicant American Bioproducts Co.

K number K943515

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KFF 1995-05-23

THE STACHROM HEPARIN ASSAY KIT

Applicant American Bioproducts Co.

K number K925433

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KFF 1995-05-11

STACLOT HEPARIN TEST KIT

Applicant American Bioproducts Co.

K number K943517

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KFF 1995-05-10

HEPARIN MANAGEMENT TEST CARD; HMT CARD

Applicant Cardiovascular Diagnostics, Inc.

K number K943283

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KFF 1994-05-06

HEMOLAB HEPARICHROM ASSAY

Applicant Biomerieux Vitek, Inc.

K number K934274

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KFF 1994-02-07

IL TEST HEPARIN (XA), PN 84699-15

Applicant Instrumentation Laboratory CO

K number K935212

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KFF 1994-01-27

SPECTROLYSE HEPARIN KIT

Applicant Biopool AB

K number K923499

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KFF 1993-06-28

BERICHROM HEPARIN

Applicant Behring Diagnostics, Inc.

K number K925200

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KFF 1991-05-10

HITT BY HEMOCHRON(R)

Applicant International Technidyne Corp.

K number K910181

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KFF 1991-04-29

HEPARIN CONTROLS, HIGH AND LOW

Applicant Sigma Diagnostics, Inc.

K number K910741

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KFF 1990-11-29

HEMOCHRON(R) HEPARIN RESPONSE TEST

Applicant Intensive Technology, Inc.

K number K904003

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KFF 1990-10-22

ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA

Applicant Organon Teknika Corp.

K number K903841

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KFF 1990-07-20

COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY

Applicant Kabi Diagnostica

K number K901874

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KFF 1990-03-15

ORTHOKROME* HEPARIN

Applicant Ortho Diagnostic Systems, Inc.

K number K900396

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KFF 1989-01-10

HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES

Applicant Hemotec, Inc.

K number K884590

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KFF 1987-01-05

IL TEST 97575-15, HEPARIN ASSAY

Applicant Instrumentation Laboratory CO

K number K864211

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KFF 1986-03-03

HEPANORM CALIBRATION PLASMA SET

Applicant American Bioproducts Co.

K number K854762

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KFF 1985-11-05

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY

Applicant Haemachem, Inc.

K number K853239

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KFF 1985-05-08

GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY

Applicant Warner-Lambert Co.

K number K850486

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KFF 1984-11-30

HEPARIN CALIBRATOR ACA

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K843202

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KFF 1984-11-30

HEPARIN ACA ANALYTICAL TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K843201

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KFF 1984-06-11

HEPARINOMETER

Applicant Western Laboratories Corp.

K number K834024

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KFF 1984-01-30

COATEST HEPARIN

Applicant Kabivitrum, Inc.

K number K833891

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KFF 1983-09-29

DIACROM * HEPARIN

Applicant Wellcome Diagnostics

K number K832373

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KFF 1981-10-02

CI-TROL HEPARIN CONTROLS, LOW/HIGH

Applicant American Dade

K number K812424

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KFF 1979-02-15

HEPARIN ASSAY

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K781479

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