FDA product code JGR: Refractometric, Total Protein
JGR is the FDA product code for refractometric, total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel. Devices under JGR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Refractometric, Total Protein |
| Device class | Class II |
| Regulation | 21 CFR 862.1635 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JGR devices
openFDA lists no recalls for product code JGR.
Frequently asked questions
What is FDA product code JGR?
JGR is the FDA product code for refractometric, total protein. It is a Class II device, regulated under 21 CFR 862.1635 and reviewed by the Clinical Chemistry panel.
What device class is JGR?
Class II, regulation 21 CFR 862.1635. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JGR
- Run a recall and safety report across every JGR manufacturer
- Watch product code JGR 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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