Identifiers
- 510(k) Number
- K093420 FDA 510(k)
- FDA Product Code
- NTI FDA 510(k)
- Models / Variants
- I030c0300 (96 Tests FDA 510(k)Kit) FDA 510(k)Tdas Cyp2d6 Software (2030-0254) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3360 FDA 510(k)
- Regulation Number
- 862.3360 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
XTAG CYP2D6 KIT V3 - Kit) by Luminex Molecular Diagnostics, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093420 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Molecular Diagnostics, Inc.
Sources (1)
- FDA 510(k) K093420 24 fields · synced Jun 18, 2026