The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for Automated Gylcohemoglobin Analyzer Hlc-723g8.
| Device ID | K131580 |
| 510k Number | K131580 |
| Device Name: | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 |
| Classification | Hemoglobin A1c Test System |
| Applicant | Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Robert L Wick |
| Correspondent | Robert L Wick 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 | 2013-05-31 |
| Decision Date | 2014-01-23 |
| Summary: | summary |