510(k) DEN040011
- Device
- AMPLICHIP CYP450 TEST, MODEL 04381866190
- Applicant
- Roche Molecular Systems, Inc.
- 510(k) number
- DEN040011
- Product code
- NTI
- Decision
- Unknown (DENG)
- Decision date
- 2004-12-23
- Date received
- 2004-12-20
- Regulation
- 862.3360
- Classification name
- Drug Metabolizing Enzyme Genotyping Systems
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- JAMES F KELLY
- Address
- 4300 Hacienda Dr. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 3002777243
- 3021047648
- 3005406097
Source Documents#
510(k) summary PDF not indicated by FDA
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| 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 |
| K101683 | INFINITI CYP2C19 ASSAY | Autogenomics, Incorporated | 2010-10-25 |
| 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 |