COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN— 510(k) K961824
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K961824 for COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN, Substantially Equivalent on 1996-07-23. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code DCF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Recent devices under product code DCF
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