COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY— 510(k) K121610
Substantially EquivalentRoche Diagnostics Operations
FDA 510(k) clearance K121610 for COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY, Substantially Equivalent on 2013-08-08. Applicant: Roche Diagnostics Operations.
Clearance details
- Applicant
- Roche Diagnostics Operations
- Product code
- Code PDJ
- Advisory panel
- Clinical Chemistry
- 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.