Panels › Hematology › Product code KFF · Class 2
Assay, Heparin
Regulation 864.7525
1510(k)s in 12 months (47 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in KFF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K260214 | STA® - Liquid Anti-Xa Diagnostica Stago, Inc. | KFF |
| Oct 4, 2022 | K213464 | HemosIL Liquid Anti-Xa Instrumentation Laboratory CO | KFF |
| Aug 22, 2017 | K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls Siemens Healthcare Diagnostics Prodcts GmbH, DE | KFF |
| Oct 26, 2011 | K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH Diagnostica Stago, Inc., IT | KFF |
| Jun 2, 2009 | K090209 | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS Instrumentation Laboratory CO | KFF |
| May 24, 2006 | K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 Hyphen Biomed | KFF |
| Aug 23, 2002 | K013305 | ENOXAPARIN TEST CARD Cardiovascular Diagnostics, Inc. | KFF |
| Apr 16, 2002 | K013637 | ACTICHROME HEPARIN (ANTI-FIIA) American Diagnostica, Inc. | KFF |
| Mar 8, 2002 | K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 American Diagnostica, Inc. | KFF |
| Jun 7, 2001 | K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN Diagnostica-Stago | KFF |
| Jun 6, 2001 | K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS International Technidyne Corp. | KFF |
| Nov 3, 1998 | K983178 | COAMATIC HEPARIN Instrumentation Laboratory CO | KFF |
| Mar 19, 1998 | K980242 | IL TEST HEPARIN Instrumentation Laboratory CO | KFF |
| Aug 12, 1997 | K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) Medical Diagnostic Technologies, Inc. | KFF |
| Mar 18, 1997 | K965076 | MDA HEPARIN ANTI-X ASSAY Organon Teknika Corp. | KFF |
| Feb 14, 1996 | K952667 | CHROM Z-HEPARIN, CAT. NO 5242 Helena Laboratories | KFF |
| Nov 20, 1995 | K952514 | COACUTE HEPARIN Chromogenix AB | KFF |
| Sep 26, 1995 | K943520 | HEPARIN CONTROL KIT American Bioproducts Co. | KFF |
| Sep 26, 1995 | K943519 | HBPM/LMWH CONTROL KIT American Bioproducts Co. | KFF |
| Sep 26, 1995 | K943514 | THE HEPANORM HBPM/LMWH KIT American Bioproducts Co. | KFF |
| Aug 31, 1995 | K943516 | ROTACHROM HBPM/LMWH TEST KIT American Bioproducts Co. | KFF |
| Aug 31, 1995 | K943515 | ROTACHROM HEPARIN TEST KIT American Bioproducts Co. | KFF |
| May 23, 1995 | K925433 | THE STACHROM HEPARIN ASSAY KIT American Bioproducts Co. | KFF |
| May 11, 1995 | K943517 | STACLOT HEPARIN TEST KIT American Bioproducts Co. | KFF |
| May 10, 1995 | K943283 | HEPARIN MANAGEMENT TEST CARD; HMT CARD Cardiovascular Diagnostics, Inc. | KFF |
| May 6, 1994 | K934274 | HEMOLAB HEPARICHROM ASSAY Biomerieux Vitek, Inc. | KFF |
| Feb 7, 1994 | K935212 | IL TEST HEPARIN (XA), PN 84699-15 Instrumentation Laboratory CO | KFF |
| Jan 27, 1994 | K923499 | SPECTROLYSE HEPARIN KIT Biopool AB, CA | KFF |
| Jun 28, 1993 | K925200 | BERICHROM HEPARIN Behring Diagnostics, Inc. | KFF |
| May 10, 1991 | K910181 | HITT BY HEMOCHRON(R) International Technidyne Corp. | KFF |
| Apr 29, 1991 | K910741 | HEPARIN CONTROLS, HIGH AND LOW Sigma Diagnostics, Inc. | KFF |
| Nov 29, 1990 | K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST Intensive Technology, Inc. | KFF |
| Oct 22, 1990 | K903841 | ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA Organon Teknika Corp. | KFF |
| Jul 20, 1990 | K901874 | COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY Kabi Diagnostica | KFF |
| Mar 15, 1990 | K900396 | ORTHOKROME* HEPARIN Ortho Diagnostic Systems, Inc. | KFF |
| Jan 10, 1989 | K884590 | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES Hemotec, Inc. | KFF |
| Jan 5, 1987 | K864211 | IL TEST 97575-15, HEPARIN ASSAY Instrumentation Laboratory CO | KFF |
| Mar 3, 1986 | K854762 | HEPANORM CALIBRATION PLASMA SET American Bioproducts Co. | KFF |
| Nov 5, 1985 | K853239 | HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY Haemachem, Inc. | KFF |
| May 8, 1985 | K850486 | GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY Warner-Lambert Co. | KFF |
| Nov 30, 1984 | K843202 | HEPARIN CALIBRATOR ACA E.I. Dupont DE Nemours & Co., Inc. | KFF |
| Nov 30, 1984 | K843201 | HEPARIN ACA ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | KFF |
| Jun 11, 1984 | K834024 | HEPARINOMETER Western Laboratories Corp. | KFF |
| Jan 30, 1984 | K833891 | COATEST HEPARIN Kabivitrum, Inc. | KFF |
| Sep 29, 1983 | K832373 | DIACROM * HEPARIN Wellcome Diagnostics | KFF |
| Oct 2, 1981 | K812424 | CI-TROL HEPARIN CONTROLS, LOW/HIGH American Dade | KFF |
| Feb 15, 1979 | K781479 | HEPARIN ASSAY Dade, Baxter Travenol Diagnostics, Inc. | KFF |
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