The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Tina-quant Hemoglobin A1cdx Gen.3.
| Device ID | K193053 |
| 510k Number | K193053 |
| Device Name: | Tina-quant Hemoglobin A1cDx Gen.3 |
| Classification | Hemoglobin A1c Test System |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Rd Indianapolis, IN 46250 |
| Contact | Leslie Patterson |
| Correspondent | Leslie Patterson Roche Diagnostics Operations (RDO) 9115 Hague Rd 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 | 2019-11-01 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336157824 | K193053 | 000 |