ROCHE AMPLICHIP CYP450 TEST— 510(k) K043576
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K043576 for ROCHE AMPLICHIP CYP450 TEST, Substantially Equivalent on 2005-01-10. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code NTI
- Device class
- Class 2
- Regulation
- 21 CFR 862.3360
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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