FDA product code JLQ: Spectrophotometric Method, Pregnanetriol
JLQ is the FDA product code for spectrophotometric method, pregnanetriol. It is a Class I device, regulated under 21 CFR 862.1610 and reviewed by the Clinical Chemistry panel. Devices under JLQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Spectrophotometric Method, 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 JLQ devices
openFDA lists no recalls for product code JLQ.
Frequently asked questions
What is FDA product code JLQ?
JLQ is the FDA product code for spectrophotometric method, pregnanetriol. It is a Class I device, regulated under 21 CFR 862.1610 and reviewed by the Clinical Chemistry panel.
What device class is JLQ?
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 JLQ
- Run a recall and safety report across every JLQ manufacturer
- Watch product code JLQ 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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