FDA product code JLF: Radioimmunoassay, Etiocholanolone
JLF is the FDA product code for radioimmunoassay, etiocholanolone. It is a Class I device, regulated under 21 CFR 862.1285 and reviewed by the Clinical Chemistry panel. Devices under JLF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Etiocholanolone |
| Device class | Class I |
| Regulation | 21 CFR 862.1285 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLF devices
openFDA lists no recalls for product code JLF.
Frequently asked questions
What is FDA product code JLF?
JLF is the FDA product code for radioimmunoassay, etiocholanolone. It is a Class I device, regulated under 21 CFR 862.1285 and reviewed by the Clinical Chemistry panel.
What device class is JLF?
Class I, regulation 21 CFR 862.1285. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLF
- Run a recall and safety report across every JLF manufacturer
- Watch product code JLF 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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