FDA product code JLR: Gas Chromatography, Pregnanetriol
JLR is the FDA product code for gas chromatography, pregnanetriol. It is a Class I device, regulated under 21 CFR 862.1610 and reviewed by the Clinical Chemistry panel. Devices under JLR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Pregnanetriol |
| Device class | Class I |
| Regulation | 21 CFR 862.1610 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLR devices
openFDA lists no recalls for product code JLR.
Frequently asked questions
What is FDA product code JLR?
JLR is the FDA product code for gas chromatography, pregnanetriol. It is a Class I device, regulated under 21 CFR 862.1610 and reviewed by the Clinical Chemistry panel.
What device class is JLR?
Class I, regulation 21 CFR 862.1610. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLR
- Run a recall and safety report across every JLR manufacturer
- Watch product code JLR 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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