510(k) K160571
K160571 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay". The FDA issued a decision of Substantially Equivalent on December 19, 2016. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2016
- Date Received
- February 29, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A1c Test System
- Device Class
- Class II
- Regulation Number
- 862.1373
- Review Panel
- CH
- Submission Type
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.