COBAS-FP REAGENTS AND CALIBRATORS— 510(k) K941712
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K941712 for COBAS-FP REAGENTS AND CALIBRATORS, Substantially Equivalent on 1994-06-13. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LGJ
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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