The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Tina-quant Hemoglobin A1c Gen.2 Test System.
| Device ID | K072714 |
| 510k Number | K072714 |
| Device Name: | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa A Bush |
| Correspondent | Theresa A Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-25 |
| Decision Date | 2008-04-18 |
| Summary: | summary |