cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay— 510(k) K160571
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K160571 for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay, Substantially Equivalent on 2016-12-19. Applicant: Roche Diagnostics Operations (Rdo).
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- 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.