The following data is part of a premarket notification filed by Roche Diagnostics Operations with the FDA for Cobas C 501 Tina-quant Hba1cdx Gen.3 Assay.
| Device ID | K121610 |
| 510k Number | K121610 |
| Device Name: | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY |
| Classification | Hemoglobin A1c Test System |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS 9115 Hague Rd Indianapolis, IN 46256 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck ROCHE DIAGNOSTICS OPERATIONS 9115 Hague Rd Indianapolis, IN 46256 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2013-08-08 |
| Summary: | summary |