The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Cobas C513 Analyzer, Cobas C13 Tina-quant Hba1cdx Gen.3 Assay.
| Device ID | K160571 |
| 510k Number | K160571 |
| Device Name: | Cobas C513 Analyzer, Cobas C13 Tina-quant HbA1cDx Gen.3 Assay |
| Classification | Hemoglobin A1c Test System |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Contact | David Tribbett |
| Correspondent | David Tribbett Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630946327 | K160571 | 000 |