510(k) K121610
K121610 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations for the device "COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY". The FDA issued a decision of Substantially Equivalent on August 8, 2013. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Roche Diagnostics Operations has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2013
- Date Received
- June 1, 2012
- 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.