XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
FDA 510(k) clearance K093420 · decided 2010-08-26
Clearance details
- K-number
- K093420
- Device name
- XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-03
- Decision date
- 2010-08-26
- Days to decision
- 296 days
- Clearance type
- Traditional
- Product code
- NTI
- Device class
- 2
- Regulation number
- 862.3360
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Toronto, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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| VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (K120466) | Nanosphere, Inc. | 2012-11-06 |
| INFINITI CYP2C19 ASSAY (K101683) | Autogenomics, Incorporated | 2010-10-25 |
| INVADER UGT1A1 MOLECULAR ASSAY (K051824) | Third Wave Technologies, Inc. | 2005-08-18 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnosti recall (Z-3112-2011) | Luminex Corporation | 2011-08-31 |