FDA product code GIS: Test, Fibrinogen
GIS is the FDA product code for test, fibrinogen. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. FDA has cleared 13 510(k) submissions under GIS, from 13 different applicants. The average 510(k) review took 118 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Test, Fibrinogen |
| Device class | Class II |
| Regulation | 21 CFR 864.7340 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GIS clearance
Top GIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories | 1 | 2016-01-31 |
| R2 Diagnostics, Inc. | 1 | 2004-11-29 |
| Kamiya Biomedical Co. | 1 | 1999-12-06 |
| Ortho Diagnostic Systems, Inc. | 1 | 1996-11-29 |
| Diagnostic Specialties | 1 | 1994-08-30 |
8 more applicants have GIS clearances. See the full list in Caduvo.
Most recent GIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143470 | Diazyme Laboratories | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | 2016-01-31 | 422 |
| K042919 | R2 Diagnostics, Inc. | FIBROTEK FIB | 2004-11-29 | 38 |
| K993482 | Kamiya Biomedical Co. | K-ASSAY FIBRINOGEN | 1999-12-06 | 53 |
| K963902 | Ortho Diagnostic Systems, Inc. | QUANTITATIVE FIBRINOGEN ASSAY | 1996-11-29 | 63 |
| K941001 | Diagnostic Specialties | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | 1994-08-30 | 182 |
Recalls for GIS devices
openFDA lists no recalls for product code GIS.
Frequently asked questions
What is FDA product code GIS?
GIS is the FDA product code for test, fibrinogen. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is GIS?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k).
How long does a 510(k) take for product code GIS?
Across 13 cleared submissions the average was 118 days from receipt to decision (median 82).
Which companies have the most GIS clearances?
Diazyme Laboratories (1); R2 Diagnostics, Inc. (1); Kamiya Biomedical Co. (1); Ortho Diagnostic Systems, Inc. (1); Diagnostic Specialties (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GIS
- Run a recall and safety report across every GIS manufacturer
- Watch product code GIS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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