COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II— 510(k) K000534
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K000534 for COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II, Substantially Equivalent on 2000-04-05. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DHR
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