FDA product code LDB: U.V. Spectrometry, Carbamazepine
LDB is the FDA product code for u.v. spectrometry, carbamazepine. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. Devices under LDB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | U.V. Spectrometry, Carbamazepine |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LDB devices
openFDA lists no recalls for product code LDB.
Frequently asked questions
What is FDA product code LDB?
LDB is the FDA product code for u.v. spectrometry, carbamazepine. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is LDB?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LDB
- Run a recall and safety report across every LDB manufacturer
- Watch product code LDB 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