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 |