FDA product code LAC: High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites
LAC is the FDA product code for high pressure liquid chromatography, cocaine and cocaine metabolites. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. Devices under LAC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LAC devices
openFDA lists no recalls for product code LAC.
Frequently asked questions
What is FDA product code LAC?
LAC is the FDA product code for high pressure liquid chromatography, cocaine and cocaine metabolites. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is LAC?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LAC
- Run a recall and safety report across every LAC manufacturer
- Watch product code LAC 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 Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times