Product code GIS
- Device name
- Test, Fibrinogen
- 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 |
|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | Diazyme Laboratories | 2016-01-31 |
| K042919 | FIBROTEK FIB | R2 Diagnostics, Inc. | 2004-11-29 |
| K993482 | K-ASSAY FIBRINOGEN | Kamiya Biomedical Co. | 1999-12-06 |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | 1996-11-29 |
| K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | Diagnostic Specialties | 1994-08-30 |
| K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT | Biomerieux Vitek, Inc. | 1993-05-18 |
| K923921 | IL TEST PT FIBRINOGEN HS | Instrumentation Laboratory CO | 1992-10-26 |
| K913061 | FIBRINOGEN DETERMINATION KIT | Sigma Diagnostics, Inc. | 1991-10-09 |
| K910636 | ABS CADKIT | Panbio, Inc. | 1991-04-29 |
| K903874 | FIBRINOTEST(TM) - FIBRINOGEN ASSAY | Haemachem, Inc. | 1991-02-14 |
| K881685 | FIBRINOGENTEST-O | Diatech, Inc. | 1988-08-09 |
| K881150 | KINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1988-03-28 |
| K781880 | ASSAY KIT, THROMBO-SCREEN | Pacific Hemostasis | 1978-12-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816426021082 | K-ASSAY® Fibrinogen Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC | 2017-01-13 |
| 00816426021075 | K-ASSAY® Fibrinogen Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | 2017-01-13 |
| 00859394006040 | Fibrotek | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006191 | FIB Calibrator | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 00817089020689 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00817089020696 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 00817089020672 | Diazyme | DIAZYME LABORATORIES, INC. | 2016-11-03 |
| 08426950573494 | HemosIL Q.F.A. Thrombin (Bovine) - 5 mL | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950573500 | HemosIL Q.F.A. Thrombin (Bovine) - 2 mL | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 00845275000580 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000597 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000627 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000825 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000849 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00845275000856 | Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 2016-09-16 |
| 00816426020214 | K-ASSAY® Fibrinogen Reagent + Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00816426020351 | K-ASSAY® Fibrinogen Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |
| 00816426020658 | K-ASSAY® Fibrinogen Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC | 2016-09-16 |