FDA product code PFK: Quality Control For Molecular Immunohematology Tests
PFK is the FDA product code for quality control for molecular immunohematology tests. It is a Class II device, regulated under 21 CFR 864.9650 and reviewed by the Pathology panel. Devices under PFK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
Classification
| Field | Value |
|---|---|
| Device name | Quality Control For Molecular Immunohematology Tests |
| Device class | Class II |
| Regulation | 21 CFR 864.9650 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PFK devices
openFDA lists no recalls for product code PFK.
Frequently asked questions
What is FDA product code PFK?
PFK is the FDA product code for quality control for molecular immunohematology tests. It is a Class II device, regulated under 21 CFR 864.9650 and reviewed by the Pathology panel.
What device class is PFK?
Class II, regulation 21 CFR 864.9650. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PFK
- Run a recall and safety report across every PFK manufacturer
- Watch product code PFK 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times