COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS— 510(k) K852319
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K852319 for COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS, Substantially Equivalent on 1985-06-25. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LAN
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nutley, NY, US
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