FDA Product Code
FDA Product Code KFF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7525
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | 2026-09-24 | Special | PDF ↗ |
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022-10-04 | Special | PDF ↗ |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | Siemens Healthcare Diagnostics Prodcts GmbH | 2017-08-22 | Traditional | PDF ↗ |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | Diagnostica Stago, Inc. | 2011-10-26 | Traditional | PDF ↗ |
| K090209 | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | Instrumentation Laboratory CO | 2009-06-02 | Traditional | PDF ↗ |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | Hyphen Biomed | 2006-05-24 | Traditional | PDF ↗ |
| K013305 | ENOXAPARIN TEST CARD | Cardiovascular Diagnostics, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | American Diagnostica, Inc. | 2002-04-16 | Traditional | PDF ↗ |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | American Diagnostica, Inc. | 2002-03-08 | Traditional | PDF ↗ |
| K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | Diagnostica-Stago | 2001-06-07 | Traditional | PDF ↗ |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | International Technidyne Corp. | 2001-06-06 | Traditional | PDF ↗ |
| K983178 | COAMATIC HEPARIN | Instrumentation Laboratory CO | 1998-11-03 | Traditional | PDF ↗ |
| K980242 | IL TEST HEPARIN | Instrumentation Laboratory CO | 1998-03-19 | Traditional | PDF ↗ |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | Medical Diagnostic Technologies, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K965076 | MDA HEPARIN ANTI-X ASSAY | Organon Teknika Corp. | 1997-03-18 | Traditional | PDF ↗ |
| K952667 | CHROM Z-HEPARIN, CAT. NO 5242 | Helena Laboratories | 1996-02-14 | Traditional | PDF ↗ |
| K952514 | COACUTE HEPARIN | Chromogenix AB | 1995-11-20 | Traditional | PDF ↗ |
| K943519 | HBPM/LMWH CONTROL KIT | American Bioproducts Co. | 1995-09-26 | Traditional | PDF ↗ |
| K943520 | HEPARIN CONTROL KIT | American Bioproducts Co. | 1995-09-26 | Traditional | PDF ↗ |
| K943514 | THE HEPANORM HBPM/LMWH KIT | American Bioproducts Co. | 1995-09-26 | Traditional | PDF ↗ |
| K943515 | ROTACHROM HEPARIN TEST KIT | American Bioproducts Co. | 1995-08-31 | Traditional | PDF ↗ |
| K943516 | ROTACHROM HBPM/LMWH TEST KIT | American Bioproducts Co. | 1995-08-31 | Traditional | PDF ↗ |
| K925433 | THE STACHROM HEPARIN ASSAY KIT | American Bioproducts Co. | 1995-05-23 | Traditional | PDF ↗ |
| K943517 | STACLOT HEPARIN TEST KIT | American Bioproducts Co. | 1995-05-11 | Traditional | PDF ↗ |
| K943283 | HEPARIN MANAGEMENT TEST CARD; HMT CARD | Cardiovascular Diagnostics, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K934274 | HEMOLAB HEPARICHROM ASSAY | Biomerieux Vitek, Inc. | 1994-05-06 | Traditional | PDF ↗ |
| K935212 | IL TEST HEPARIN (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994-02-07 | Traditional | PDF ↗ |
| K923499 | SPECTROLYSE HEPARIN KIT | Biopool AB | 1994-01-27 | Traditional | PDF ↗ |
| K925200 | BERICHROM HEPARIN | Behring Diagnostics, Inc. | 1993-06-28 | Traditional | PDF ↗ |
| K910181 | HITT BY HEMOCHRON(R) | International Technidyne Corp. | 1991-05-10 | Traditional | PDF ↗ |
| K910741 | HEPARIN CONTROLS, HIGH AND LOW | Sigma Diagnostics, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | Intensive Technology, Inc. | 1990-11-29 | Traditional | PDF ↗ |
| K903841 | ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA | Organon Teknika Corp. | 1990-10-22 | Traditional | PDF ↗ |
| K901874 | COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY | Kabi Diagnostica | 1990-07-20 | Traditional | PDF ↗ |
| K900396 | ORTHOKROME* HEPARIN | Ortho Diagnostic Systems, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K884590 | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES | Hemotec, Inc. | 1989-01-10 | Traditional | PDF ↗ |
| K864211 | IL TEST 97575-15, HEPARIN ASSAY | Instrumentation Laboratory CO | 1987-01-05 | Traditional | PDF ↗ |
| K854762 | HEPANORM CALIBRATION PLASMA SET | American Bioproducts Co. | 1986-03-03 | Traditional | PDF ↗ |
| K853239 | HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY | Haemachem, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K850486 | GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY | Warner-Lambert Co. | 1985-05-08 | Traditional | PDF ↗ |
| K843201 | HEPARIN ACA ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1984-11-30 | Traditional | PDF ↗ |
| K843202 | HEPARIN CALIBRATOR ACA | E.I. Dupont DE Nemours & Co., Inc. | 1984-11-30 | Traditional | PDF ↗ |
| K834024 | HEPARINOMETER | Western Laboratories Corp. | 1984-06-11 | Traditional | PDF ↗ |
| K833891 | COATEST HEPARIN | Kabivitrum, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K832373 | DIACROM * HEPARIN | Wellcome Diagnostics | 1983-09-29 | Traditional | PDF ↗ |
| K812424 | CI-TROL HEPARIN CONTROLS, LOW/HIGH | American Dade | 1981-10-02 | Traditional | PDF ↗ |
| K781479 | HEPARIN ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1979-02-15 | Traditional | PDF ↗ |
Product code KFF · Class II · Hematology. Data: openFDA.