COBAS CORE FERRITIN EIA— 510(k) K920829
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K920829 for COBAS CORE FERRITIN EIA, Substantially Equivalent on 1992-06-19. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code JMG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code JMG
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