FDA product code JPF: Prothrombin-Proconvertin And Thrombotest
JPF is the FDA product code for prothrombin-proconvertin and thrombotest. It is a Class II device, regulated under 21 CFR 864.7735 and reviewed by the Hematology panel. Devices under JPF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for JPF devices.
Classification
| Field | Value |
|---|---|
| Device name | Prothrombin-Proconvertin And Thrombotest |
| Device class | Class II |
| Regulation | 21 CFR 864.7735 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Recalls for JPF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-03-31.
Frequently asked questions
What is FDA product code JPF?
JPF is the FDA product code for prothrombin-proconvertin and thrombotest. It is a Class II device, regulated under 21 CFR 864.7735 and reviewed by the Hematology panel.
What device class is JPF?
Class II, regulation 21 CFR 864.7735. Typical premarket route: 510(k) exempt.
Have JPF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code JPF
- Run a recall and safety report across every JPF manufacturer
- Watch product code JPF 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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