ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR— 510(k) K914750
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K914750 for ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR, Substantially Equivalent on 1991-11-22. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JIX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
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