XTAG CYP2C19 KIT V3— 510(k) K131565
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K131565 for XTAG CYP2C19 KIT V3, Substantially Equivalent on 2013-09-11. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Product code
- Code NTI
- Device class
- Class 2
- Regulation
- 21 CFR 862.3360
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, Ontario, CA
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