FDA product code JLT: Acid, Pyruvic, Enzymatic (U.V.)
JLT is the FDA product code for acid, pyruvic, enzymatic (u.v.). It is a Class I device, regulated under 21 CFR 862.1655 and reviewed by the Clinical Chemistry panel. Devices under JLT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Pyruvic, Enzymatic (U.V.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1655 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLT devices
openFDA lists no recalls for product code JLT.
Frequently asked questions
What is FDA product code JLT?
JLT is the FDA product code for acid, pyruvic, enzymatic (u.v.). It is a Class I device, regulated under 21 CFR 862.1655 and reviewed by the Clinical Chemistry panel.
What device class is JLT?
Class I, regulation 21 CFR 862.1655. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLT
- Run a recall and safety report across every JLT manufacturer
- Watch product code JLT 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times