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..
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code DHR
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.