The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Tina-quant Hba1c Gen.2.
| Device ID | K110313 |
| 510k Number | K110313 |
| Device Name: | TINA-QUANT HBA1C GEN.2 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-02 |
| Decision Date | 2011-12-23 |
| Summary: | summary |