Clearance Summary
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay received FDA 510(k) clearance under submission number K160571, sponsored by Roche Diagnostics Operations (Rdo). The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2016-12-19.
- Submission: K160571
- Applicant / Sponsor: Roche Diagnostics Operations (Rdo)
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1373
- Decision date: 2016-12-19
Classification & Regulation
This clearance is catalogued under FDA product code PDJ and 21 CFR 862.1373, within the Clinical Chemistry review panel as a Class II device.