ROCHE AMPLICHIP CYP450 TEST
FDA 510(k) clearance K043576 · decided 2005-01-10
Clearance details
- K-number
- K043576
- Device name
- ROCHE AMPLICHIP CYP450 TEST
- Applicant
- Roche Molecular Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-27
- Decision date
- 2005-01-10
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- NTI
- Device class
- 2
- Regulation number
- 862.3360
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics recall (Z-0734-2007) | Roche Molecular Systems, Inc. | 2007-04-11 |
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