The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for G8 Automated Hplc Analyzer, Model Hlc-723 G8.
| Device ID | K071132 |
| 510k Number | K071132 |
| Device Name: | G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Charles P Gill |
| Correspondent | Charles P Gill Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2008-09-16 |
| Summary: | summary |