The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for A1c 2.2 Plus - Automated Glycohemoglobin Analyzer.
| Device ID | K972265 |
| 510k Number | K972265 |
| Device Name: | A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Contact | Lori Robinson |
| Correspondent | Lori Robinson TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1997-09-25 |