FDA product code JNA: Vapor Pressure, Osmolality Of Serum & Urine
JNA is the FDA product code for vapor pressure, osmolality of serum & urine. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel. Devices under JNA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Vapor Pressure, Osmolality Of Serum & Urine |
| Device class | Class I |
| Regulation | 21 CFR 862.1540 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JNA devices
openFDA lists no recalls for product code JNA.
Frequently asked questions
What is FDA product code JNA?
JNA is the FDA product code for vapor pressure, osmolality of serum & urine. It is a Class I device, regulated under 21 CFR 862.1540 and reviewed by the Clinical Chemistry panel.
What device class is JNA?
Class I, regulation 21 CFR 862.1540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JNA
- Run a recall and safety report across every JNA manufacturer
- Watch product code JNA 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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