FDA product code JLY: Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid
JLY is the FDA product code for phosphoglycerate mutase (colorimetric), 2,3-diphosphoglyceric acid. It is a Class I device, regulated under 21 CFR 862.1255 and reviewed by the Clinical Chemistry panel. Devices under JLY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid |
| Device class | Class I |
| Regulation | 21 CFR 862.1255 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLY devices
openFDA lists no recalls for product code JLY.
Frequently asked questions
What is FDA product code JLY?
JLY is the FDA product code for phosphoglycerate mutase (colorimetric), 2,3-diphosphoglyceric acid. It is a Class I device, regulated under 21 CFR 862.1255 and reviewed by the Clinical Chemistry panel.
What device class is JLY?
Class I, regulation 21 CFR 862.1255. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLY
- Run a recall and safety report across every JLY manufacturer
- Watch product code JLY 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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