510(k) K101683
- Device
- INFINITI CYP2C19 ASSAY
- Applicant
- AUTOGENOMICS, INCORPORATED
- 510(k) number
- K101683
- Product code
- NTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-10-25
- Date received
- 2010-06-15
- Regulation
- 862.3360
- Classification name
- Drug Metabolizing Enzyme Genotyping Systems
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EVELYN G LOPEZ
- Address
- 2980 Scott St. Vista CA US 92081 92081
FDA Registration Numbers#
- 3002777243
- 3021047648
- 3005406097
Source Documents#
Other 510(k) Records For Product Code NTI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220026 | Genomadix Cube CYP2C19 System | Genomadix, Inc. | 2023-03-21 |
| K170492 | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | 2017-08-11 |
| K131565 | XTAG CYP2C19 KIT V3 | Luminex Molecular Diagnostics, Inc. | 2013-09-11 |
| K123891 | SPARTAN RX CYP2C19 TEST SYSTEM | Spartan Bioscience, Inc. | 2013-08-12 |
| K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | Luminex Molecular Diagnostics, Inc. | 2013-05-21 |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | Nanosphere, Inc. | 2012-11-06 |
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) | Luminex Molecular Diagnostics, Inc. | 2010-08-26 |
| K051824 | INVADER UGT1A1 MOLECULAR ASSAY | Third Wave Technologies, Inc. | 2005-08-18 |
| K043576 | ROCHE AMPLICHIP CYP450 TEST | Roche Molecular Systems, Inc. | 2005-01-10 |
| DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 | Roche Molecular Systems, Inc. | 2004-12-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary