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.
| Device ID | K052464 |
| 510k Number | K052464 |
| Device Name: | TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose 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 | 2005-09-08 |
| Decision Date | 2005-09-30 |
| Summary: | summary |