Product code KQJ
- Device name
- System, Fibrinogen Determination
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7340
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | 2025-07-24 |
| K073367 | HEMOSIL FIBRINOGEN-C | Instrumentation Laboratory CO | 2007-12-27 |
| K050928 | DADE THROMBIN REAGENT | Dade Behring, Inc. | 2005-06-29 |
| K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | Sigma Diagnostics, Inc. | 1997-10-09 |
| K970189 | FIF TM | Panbio, Inc. | 1997-05-21 |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | Crestat Diagnostics, Inc. | 1997-04-16 |
| K934326 | MULTIFIBREN U | Behring Diagnostics, Inc. | 1994-04-19 |
| K931721 | IL TEST FIBRINOGEN-C | Instrumentation Laboratory CO | 1993-08-13 |
| K922416 | FIBRINOGEN RID TEST KIT | The Binding Site, Ltd. | 1993-03-09 |
| K925988 | MULTIFIBREN | Behring Diagnostics, Inc. | 1993-03-01 |
| K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | International Technidyne Corp. | 1992-09-22 |
| K920258 | QBC FIBRINOGEN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-06-26 |
| K900939 | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) | Incstar Corp. | 1990-05-16 |
| K900895 | COAG-A-MATE - RA4 | Organon Teknika Corp. | 1990-04-16 |
| K896052 | FIBRINOGEN ASSAY KIT | Medical Diagnostic Technologies, Inc. | 1989-11-09 |
| K884179 | TURBOX FIBRINOGEN | Unipath , Ltd. | 1988-12-20 |
| K841366 | DIA FIBRIN | Diatech, Inc. | 1984-06-01 |
| K841020 | FIBRINOGEN ASSAY KIT | Helena Laboratories | 1984-05-02 |
| K840211 | FIBRI-PREST AUTOMATE HA34 | Wellcome Diagnostics | 1984-03-02 |
| K834571 | FIBRINOGEN TEST | Diatech, Inc. | 1984-02-04 |
| K812629 | ACA FIBRINOGEN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-08 |
| K812570 | LABCER FIBRINOGEN ASSAY KIT & CALIBR. | Sherwood Medical Co. | 1981-10-02 |
| K812108 | LOW FIBRINOGEN CONTROL | Bio/Data Corp. | 1981-09-24 |
| K811069 | FIBRINOGEN CONTROL PLASMA | American Dade | 1981-07-10 |
| K810058 | ORTHO QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | 1981-02-26 |
| K801926 | SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA | Sigma Chemical Co. | 1980-09-09 |
| K800826 | FIBRINOGEN SCREEN | Pacific Hemostasis | 1980-05-30 |
| K792563 | THROMBOKINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1980-01-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414640273 | Dade Owren's Veronal Buffer | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019500 | Dade Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019494 | Dade Owren's Veronal Buffer | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019517 | Dade Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019524 | Dade Data-Fi Abnormal Fibrinogen Control | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768019845 | Dade CA System Buffer | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018503 | Multifibren U | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018541 | Multifibren U | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640372 | Dade Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640266 | Dade Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640150 | Dade Data-Fi Abnormal Fibrinogen Control | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639901 | Dade CA System Buffer | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639741 | Multifibren U | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639734 | Multifibren U | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640532 | Kaolin Suspension | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| G0561009890 | Calcium Chloride | Bio/Data Corporation | 2023-08-30 |
| 05051700010726 | Human Fibrinogen BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 08426950451976 | HemosIL Low Fibrinogen Control | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950087618 | HemosIL Fibrinogen-C XL | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950478676 | HemosIL Fibrinogen-C | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 13607450006749 | STA® - Fibrinogen 5 | DIAGNOSTICA STAGO | 2016-09-15 |
| 15391521420821 | TriniCLOT™ Thrombin Time 4ml | TCOAG IRELAND LIMITED | 2016-09-12 |
| 05391521420350 | TriniCLOT™ Fibrinogen Kit | TCOAG IRELAND LIMITED | 2016-09-12 |
| 15391521420814 | TriniCLOT™ Thrombin Time 1ml | TCOAG IRELAND LIMITED | 2016-09-12 |
| 15391521420722 | TriniCAL™ Fibrinogen | TCOAG IRELAND LIMITED | 2016-09-12 |
| 15391521420500 | TriniCLOT™ Imidazole Buffer | TCOAG IRELAND LIMITED | 2016-09-12 |
| 15391521420364 | TriniCLOT™ Fibrinogen 6 mL | TCOAG IRELAND LIMITED | 2016-09-12 |
| M52553790 | Helena Fibrinogen Calibrator | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553760 | Fibrinogen Assay Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553740 | Helena Thrombin Reagent | HELENA LABORATORIES CORPORATION | 2016-09-07 |