ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS— 510(k) K063520
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K063520 for ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS, Substantially Equivalent on 2007-02-16. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code OAV
- Device class
- Class 2
- Regulation
- 21 CFR 862.3840
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code OAV
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