The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for Tosoh Automated Glycohemoglobin Analyzer Hlc-723g8.
| Device ID | K200904 |
| 510k Number | K200904 |
| Device Name: | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 |
| Classification | Hemoglobin A1c Test System |
| Applicant | Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 |
| Contact | Louise Musante |
| Correspondent | Louise Musante Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2021-08-05 |