PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC— 510(k) K050026
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K050026 for PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC, Substantially Equivalent on 2005-01-31. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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