FDA product code GFX: Fibrinogen Standard
GFX is the FDA product code for fibrinogen standard. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under GFX, from 2 different applicants. The average 510(k) review took 58 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Fibrinogen Standard |
| Device class | Class II |
| Regulation | 21 CFR 864.7340 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GFX clearance
Top GFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 2 | 2007-09-19 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1981-11-24 |
Most recent GFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072304 | Dade Behring, Inc. | FIBRINOGEN CALIBRATOR KIT | 2007-09-19 | 33 |
| K994341 | Dade Behring, Inc. | FIBRINOGEN CALIBRATOR KIT | 2000-03-03 | 71 |
| K812628 | E.I. Dupont DE Nemours & Co., Inc. | ACA FIBRINOGEN CALIBRATOR | 1981-11-24 | 70 |
Recalls for GFX devices
openFDA lists no recalls for product code GFX.
Frequently asked questions
What is FDA product code GFX?
GFX is the FDA product code for fibrinogen standard. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is GFX?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFX?
Across 3 cleared submissions the average was 58 days from receipt to decision (median 70).
Which companies have the most GFX clearances?
Dade Behring, Inc. (2); E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GFX
- Run a recall and safety report across every GFX manufacturer
- Watch product code GFX 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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