Device Listing 2005652753
Listing Summary#
- Listing key
- 2005652753
- Premarket submission
- K160571
- Device
- cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- PDJ
- Decision date
- 2016-12-19