Product code KFF
- Device name
- Assay, Heparin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7525
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022-10-04 |
| 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 |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | Diagnostica Stago, Inc. | 2011-10-26 |
| K090209 | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | Instrumentation Laboratory CO | 2009-06-02 |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | Hyphen Biomed | 2006-05-24 |
| K013305 | ENOXAPARIN TEST CARD | Cardiovascular Diagnostics, Inc. | 2002-08-23 |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | American Diagnostica, Inc. | 2002-04-16 |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | American Diagnostica, Inc. | 2002-03-08 |
| K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | Diagnostica-Stago | 2001-06-07 |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | International Technidyne Corp. | 2001-06-06 |
| K983178 | COAMATIC HEPARIN | Instrumentation Laboratory CO | 1998-11-03 |
| K980242 | IL TEST HEPARIN | Instrumentation Laboratory CO | 1998-03-19 |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | Medical Diagnostic Technologies, Inc. | 1997-08-12 |
| K965076 | MDA HEPARIN ANTI-X ASSAY | Organon Teknika Corp. | 1997-03-18 |
| K952667 | CHROM Z-HEPARIN, CAT. NO 5242 | Helena Laboratories | 1996-02-14 |
| K952514 | COACUTE HEPARIN | Chromogenix AB | 1995-11-20 |
| K943520 | HEPARIN CONTROL KIT | American Bioproducts Co. | 1995-09-26 |
| K943519 | HBPM/LMWH CONTROL KIT | American Bioproducts Co. | 1995-09-26 |
| K943514 | THE HEPANORM HBPM/LMWH KIT | American Bioproducts Co. | 1995-09-26 |
| K943515 | ROTACHROM HEPARIN TEST KIT | American Bioproducts Co. | 1995-08-31 |
| K943516 | ROTACHROM HBPM/LMWH TEST KIT | American Bioproducts Co. | 1995-08-31 |
| K925433 | THE STACHROM HEPARIN ASSAY KIT | American Bioproducts Co. | 1995-05-23 |
| K943517 | STACLOT HEPARIN TEST KIT | American Bioproducts Co. | 1995-05-11 |
| K943283 | HEPARIN MANAGEMENT TEST CARD; HMT CARD | Cardiovascular Diagnostics, Inc. | 1995-05-10 |
| K934274 | HEMOLAB HEPARICHROM ASSAY | Biomerieux Vitek, Inc. | 1994-05-06 |
| K935212 | IL TEST HEPARIN (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994-02-07 |
| K923499 | SPECTROLYSE HEPARIN KIT | Biopool AB | 1994-01-27 |
| K925200 | BERICHROM HEPARIN | Behring Diagnostics, Inc. | 1993-06-28 |
| K910181 | HITT BY HEMOCHRON(R) | International Technidyne Corp. | 1991-05-10 |
| K910741 | HEPARIN CONTROLS, HIGH AND LOW | Sigma Diagnostics, Inc. | 1991-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414640365 | Dade Ci-Trol Heparin Control, High | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640259 | Dade Ci-Trol Heparin Control, Low | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019531 | Dade Ci-Trol Heparin Control, High | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639864 | INNOVANCE Heparin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019548 | Dade Ci-Trol Heparin Control, Low | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768017438 | INNOVANCE Heparin | Siemens Healthcare Diagnostics Products GmbH | 2017-09-11 |
| 03663537008191 | BIOPHEN HEPARIN 6 | HYPHEN BIOMED | 2017-03-08 |
| 00842768012945 | Berichrom® Heparin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768003905 | Dade® Ci-Trol® Heparin Control, High | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768003899 | Dade® Ci-Trol® Heparin Control, Low | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 08426950472490 | HemosIL LMW Heparin Controls | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950472476 | HemosIL Liquid Heparin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950042211 | HemosIL Heparin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950580324 | HemosIL Liquid Anti-Xa | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950088196 | Coatest Heparin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950088967 | Coamatic Heparin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 10711234102176 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 10711234202111 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 10711234202104 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 10711234202098 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 10711234202081 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 10711234202036 | Hemochron Whole Blood Coagulation System | ACCRIVA DIAGNOSTICS HOLDINGS, INC. | 2016-09-22 |
| 03607450006827 | STA® - HBPM/LMWH Control | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006841 | STA® - Hepanorm® H | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006810 | STA® - Hepanorm® HBPM/LMWH | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450011791 | STA® - Liquid Anti-Xa 8 | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450009064 | Stachrom® Heparin | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006834 | STA® - Heparin Control | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450011784 | STA® - Liquid Anti-Xa 4 | DIAGNOSTICA STAGO | 2016-09-15 |
| 03663537008184 | BIOPHEN HEPARIN 3 | HYPHEN BIOMED | 2016-08-25 |