COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY— 510(k) K092603
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K092603 for COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY, Substantially Equivalent on 2009-12-04. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics
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