GIS — Test, Fibrinogen Class II
FDA product code GIS covers "Test, Fibrinogen", a Class II medical device regulated under 21 CFR 864.7340. Submissions are reviewed by the Hematology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GIS
- Device Class
- Class II
- Regulation Number
- 864.7340
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143470 | diazyme laboratories | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen | January 31, 2016 |
| K042919 | r2 diagnostics | FIBROTEK FIB | November 29, 2004 |
| K993482 | kamiya biomedical | K-ASSAY FIBRINOGEN | December 6, 1999 |
| K963902 | ortho diagnostic systems | QUANTITATIVE FIBRINOGEN ASSAY | November 29, 1996 |
| K941001 | diagnostic specialties | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | August 30, 1994 |
| K925494 | biomerieux vitek | BIOMERIEUX HEMOLAB FIBRINOMAT | May 18, 1993 |
| K923921 | instrumentation laboratory | IL TEST PT FIBRINOGEN HS | October 26, 1992 |
| K913061 | sigma diagnostics | FIBRINOGEN DETERMINATION KIT | October 9, 1991 |
| K910636 | panbio | ABS CADKIT | April 29, 1991 |
| K903874 | haemachem | FIBRINOTEST(TM) - FIBRINOGEN ASSAY | February 14, 1991 |
| K881685 | diatech | FIBRINOGENTEST-O | August 9, 1988 |
| K881150 | bio/data | KINETIC FIBRINOGEN ASSAY | March 28, 1988 |
| K781880 | pacific hemostasis | ASSAY KIT, THROMBO-SCREEN | December 4, 1978 |