XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)— 510(k) K130189
Substantially EquivalentLuminex Molecular Diagnostics, Inc.
FDA 510(k) clearance K130189 for XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE), Substantially Equivalent on 2013-05-21. 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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