GIS
13 FDA 510(k) clearances · Product code
82 daysmedian time to decision
197 days90th percentile
13clearances measured
FDA profile
- Official device name
- Test, Fibrinogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1998: 1 · 2001: 1 · 2006: 57 · 2007: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set (K143470) | Diazyme Laboratories | 2016-01-31 |
| FIBROTEK FIB (K042919) | R2 Diagnostics, Inc. | 2004-11-29 |
| K-ASSAY FIBRINOGEN (K993482) | Kamiya Biomedical Co. | 1999-12-06 |
| QUANTITATIVE FIBRINOGEN ASSAY (K963902) | Ortho Diagnostic Systems, Inc. | 1996-11-29 |
| ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (K941001) | Diagnostic Specialties | 1994-08-30 |
| BIOMERIEUX HEMOLAB FIBRINOMAT (K925494) | Biomerieux Vitek, Inc. | 1993-05-18 |
| IL TEST PT FIBRINOGEN HS (K923921) | Instrumentation Laboratory CO | 1992-10-26 |
| FIBRINOGEN DETERMINATION KIT (K913061) | Sigma Diagnostics, Inc. | 1991-10-09 |
| ABS CADKIT (K910636) | Panbio, Inc. | 1991-04-29 |
| FIBRINOTEST(TM) - FIBRINOGEN ASSAY (K903874) | Haemachem, Inc. | 1991-02-14 |
| FIBRINOGENTEST-O (K881685) | Diatech, Inc. | 1988-08-09 |
| KINETIC FIBRINOGEN ASSAY (K881150) | Bio/Data Corp. | 1988-03-28 |
| ASSAY KIT, THROMBO-SCREEN (K781880) | Pacific Hemostasis | 1978-12-04 |
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Every clearance here is in the API, with alerts when new ones post.