ORH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lamotrigine Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
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| Record | Firm | Date |
|---|---|---|
| ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL (K101305) | Ark Diagnostics, Inc. | 2010-10-29 |
| QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (K062966) | Seradyn, Inc. | 2007-01-12 |
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