Panels › Hematology › Product code GIS · Class 2
Test, Fibrinogen
Regulation 864.7340
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GIS
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio/Data Corp. | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Diagnostic Specialties | 1 | 0 |
| Diatech, Inc. | 1 | 0 |
| Diazyme Laboratories | 1 | 0 |
| Haemachem, Inc. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Kamiya Biomedical Co. | 1 | 0 |
| Ortho Diagnostic Systems, Inc. | 1 | 0 |
| Pacific Hemostasis | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2016 | K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set Diazyme Laboratories | GIS |
| Nov 29, 2004 | K042919 | FIBROTEK FIB R2 Diagnostics, Inc. | GIS |
| Dec 6, 1999 | K993482 | K-ASSAY FIBRINOGEN Kamiya Biomedical Co. | GIS |
| Nov 29, 1996 | K963902 | QUANTITATIVE FIBRINOGEN ASSAY Ortho Diagnostic Systems, Inc. | GIS |
| Aug 30, 1994 | K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT Diagnostic Specialties | GIS |
| May 18, 1993 | K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT Biomerieux Vitek, Inc. | GIS |
| Oct 26, 1992 | K923921 | IL TEST PT FIBRINOGEN HS Instrumentation Laboratory CO | GIS |
| Oct 9, 1991 | K913061 | FIBRINOGEN DETERMINATION KIT Sigma Diagnostics, Inc. | GIS |
| Apr 29, 1991 | K910636 | ABS CADKIT Panbio, Inc. | GIS |
| Feb 14, 1991 | K903874 | FIBRINOTEST(TM) - FIBRINOGEN ASSAY Haemachem, Inc. | GIS |
| Aug 9, 1988 | K881685 | FIBRINOGENTEST-O Diatech, Inc. | GIS |
| Mar 28, 1988 | K881150 | KINETIC FIBRINOGEN ASSAY Bio/Data Corp. | GIS |
| Dec 4, 1978 | K781880 | ASSAY KIT, THROMBO-SCREEN Pacific Hemostasis | GIS |
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