FDA product code JHP: Radial Immunodiffusion, Lipoproteins
JHP is the FDA product code for radial immunodiffusion, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. Devices under JHP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radial Immunodiffusion, Lipoproteins |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JHP devices
openFDA lists no recalls for product code JHP.
Frequently asked questions
What is FDA product code JHP?
JHP is the FDA product code for radial immunodiffusion, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is JHP?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JHP
- Run a recall and safety report across every JHP manufacturer
- Watch product code JHP 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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