SPARTAN RX CYP2C19 TEST SYSTEM
FDA 510(k) clearance K123891 · decided 2013-08-12
Clearance details
- K-number
- K123891
- Device name
- SPARTAN RX CYP2C19 TEST SYSTEM
- Applicant
- Spartan Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-12-18
- Decision date
- 2013-08-12
- Days to decision
- 237 days
- Clearance type
- Abbreviated
- Product code
- NTI
- Device class
- 2
- Regulation number
- 862.3360
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Redwood Shores, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Genomadix Cube CYP2C19 System (K220026) | Genomadix, Inc. | 2023-03-21 |
| xTAG CYP2D6 Kit v3 (K170492) | Luminex Molecular Diagnostics, Inc. | 2017-08-11 |
| XTAG CYP2C19 KIT V3 (K131565) | Luminex Molecular Diagnostics, Inc. | 2013-09-11 |
| XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) (K130189) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 |
| VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (K120466) | Nanosphere, Inc. | 2012-11-06 |
| INFINITI CYP2C19 ASSAY (K101683) | Autogenomics, Incorporated | 2010-10-25 |
| XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) (K093420) | Luminex Molecular Diagnostics, Inc. | 2010-08-26 |
| INVADER UGT1A1 MOLECULAR ASSAY (K051824) | Third Wave Technologies, Inc. | 2005-08-18 |
| ROCHE AMPLICHIP CYP450 TEST (K043576) | Roche Molecular Systems, Inc. | 2005-01-10 |
| AMPLICHIP CYP450 TEST, MODEL 04381866190 (DEN040011) | Roche Molecular Systems, Inc. | 2004-12-23 |
Recalls involving this device
No recalls on record reference this clearance.