FDA product code GFK: Fibrinogen Determination Standards And Controls
GFK is the FDA product code for fibrinogen determination standards and controls. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GFK. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Fibrinogen Determination Standards And Controls |
| 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 GFK clearance
Top GFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujisawa Electronics Co. | 1 | 1983-01-08 |
Most recent GFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823388 | Fujisawa Electronics Co. | TENS MAX | 1983-01-08 | 54 |
Recalls for GFK devices
openFDA lists no recalls for product code GFK.
Frequently asked questions
What is FDA product code GFK?
GFK is the FDA product code for fibrinogen determination standards and controls. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is GFK?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k).
How long does a 510(k) take for product code GFK?
Across 1 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most GFK clearances?
Fujisawa Electronics Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GFK
- Run a recall and safety report across every GFK manufacturer
- Watch product code GFK 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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