The following data is part of a premarket notification filed by Roche with the FDA for Tq Hba1c Gen3.
| Device ID | K102914 |
| 510k Number | K102914 |
| Device Name: | TQ HBA1C GEN3 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ROCHE 9115 HAGUE RD Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin ROCHE 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 | 2010-10-01 |
| Decision Date | 2011-01-20 |
| Summary: | summary |