FDA product code LCZ: U.V. Spectrometry, Primidone
LCZ is the FDA product code for u.v. spectrometry, primidone. It is a Class II device, regulated under 21 CFR 862.3680 and reviewed by the Clinical Toxicology panel. Devices under LCZ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | U.V. Spectrometry, Primidone |
| Device class | Class II |
| Regulation | 21 CFR 862.3680 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LCZ devices
openFDA lists no recalls for product code LCZ.
Frequently asked questions
What is FDA product code LCZ?
LCZ is the FDA product code for u.v. spectrometry, primidone. It is a Class II device, regulated under 21 CFR 862.3680 and reviewed by the Clinical Toxicology panel.
What device class is LCZ?
Class II, regulation 21 CFR 862.3680. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code LCZ
- Run a recall and safety report across every LCZ manufacturer
- Watch product code LCZ 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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