ROCHE STANDARDS FOR URIC ACID— 510(k) K843112
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K843112 for ROCHE STANDARDS FOR URIC ACID, Substantially Equivalent on 1984-09-13. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JIT
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