FDA Product Code
FDA Product Code GIS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7340
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | Diazyme Laboratories | 2016-01-31 | Traditional | PDF ↗ |
| K042919 | FIBROTEK FIB | R2 Diagnostics, Inc. | 2004-11-29 | Traditional | PDF ↗ |
| K993482 | K-ASSAY FIBRINOGEN | Kamiya Biomedical Co. | 1999-12-06 | Traditional | PDF ↗ |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | 1996-11-29 | Traditional | PDF ↗ |
| K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | Diagnostic Specialties | 1994-08-30 | Traditional | PDF ↗ |
| K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT | Biomerieux Vitek, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K923921 | IL TEST PT FIBRINOGEN HS | Instrumentation Laboratory CO | 1992-10-26 | Traditional | PDF ↗ |
| K913061 | FIBRINOGEN DETERMINATION KIT | Sigma Diagnostics, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K910636 | ABS CADKIT | Panbio, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K903874 | FIBRINOTEST(TM) - FIBRINOGEN ASSAY | Haemachem, Inc. | 1991-02-14 | Traditional | PDF ↗ |
| K881685 | FIBRINOGENTEST-O | Diatech, Inc. | 1988-08-09 | Traditional | PDF ↗ |
| K881150 | KINETIC FIBRINOGEN ASSAY | Bio/Data Corp. | 1988-03-28 | Traditional | PDF ↗ |
| K781880 | ASSAY KIT, THROMBO-SCREEN | Pacific Hemostasis | 1978-12-04 | Traditional | PDF ↗ |
Product code GIS · Class II · Hematology. Data: openFDA.