FDA product code GFT: Protamine Sulphate
GFT is the FDA product code for protamine sulphate. It is a Class II device, regulated under 21 CFR 864.7525 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GFT, from 2 different applicants. The average 510(k) review took 134 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Protamine Sulphate |
| Device class | Class II |
| Regulation | 21 CFR 864.7525 |
| 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 GFT clearance
Top GFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Hemotec, Inc. | 1 | 1995-03-24 |
| International Technidyne Corp. | 1 | 1991-02-26 |
Most recent GFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944115 | Medtronic Hemotec, Inc. | HEPARIN ASSAY CARTRIDGES AND CONTROLS | 1995-03-24 | 213 |
| K910105 | International Technidyne Corp. | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | 1991-02-26 | 54 |
Recalls for GFT devices
openFDA lists no recalls for product code GFT.
Frequently asked questions
What is FDA product code GFT?
GFT is the FDA product code for protamine sulphate. It is a Class II device, regulated under 21 CFR 864.7525 and reviewed by the Hematology panel.
What device class is GFT?
Class II, regulation 21 CFR 864.7525. Typical premarket route: 510(k).
How long does a 510(k) take for product code GFT?
Across 2 cleared submissions the average was 134 days from receipt to decision (median 134).
Which companies have the most GFT clearances?
Medtronic Hemotec, Inc. (1); International Technidyne Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GFT
- Run a recall and safety report across every GFT manufacturer
- Watch product code GFT 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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