FDA product code JFQ: P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin
JFQ is the FDA product code for p-phenyl-enediamine/edta (spectrophotometric), ceruloplasmin. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel. Devices under JFQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin |
| Device class | Class II |
| Regulation | 21 CFR 866.5210 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Recalls for JFQ devices
openFDA lists no recalls for product code JFQ.
Frequently asked questions
What is FDA product code JFQ?
JFQ is the FDA product code for p-phenyl-enediamine/edta (spectrophotometric), ceruloplasmin. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel.
What device class is JFQ?
Class II, regulation 21 CFR 866.5210. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JFQ
- Run a recall and safety report across every JFQ manufacturer
- Watch product code JFQ 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.