FDA Product Code
FDA Product Code NTI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3360
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023-03-21 | Abbreviated | PDF ↗ |
| K170492 | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | 2017-08-11 | Special | PDF ↗ |
| K131565 | XTAG CYP2C19 KIT V3 | Luminex Molecular Diagnostics, Inc. | 2013-09-11 | Traditional | PDF ↗ |
| K123891 | SPARTAN RX CYP2C19 TEST SYSTEM | Spartan Bioscience, Inc. | 2013-08-12 | Abbreviated | PDF ↗ |
| K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 | Traditional | PDF ↗ |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | Nanosphere, Inc. | 2012-11-06 | Traditional | PDF ↗ |
| K101683 | INFINITI CYP2C19 ASSAY | Autogenomics, Incorporated | 2010-10-25 | Abbreviated | PDF ↗ |
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) | Luminex Molecular Diagnostics, Inc. | 2010-08-26 | Traditional | PDF ↗ |
| K051824 | INVADER UGT1A1 MOLECULAR ASSAY | Third Wave Technologies, Inc. | 2005-08-18 | Traditional | PDF ↗ |
| K043576 | ROCHE AMPLICHIP CYP450 TEST | Roche Molecular Systems, Inc. | 2005-01-10 | Traditional | PDF ↗ |
| DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 | Roche Molecular Systems, Inc. | 2004-12-23 | Post-NSE | — |
Product code NTI · Class II · Clinical Toxicology. Data: openFDA.