COBAS INTEGRA REAGENT CASSETTES— 510(k) K982382
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K982382 for COBAS INTEGRA REAGENT CASSETTES, Substantially Equivalent on 1998-09-28. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code CFN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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