The following data is part of a premarket notification filed by Sakae Corporation with the FDA for A1c Igear System.
| Device ID | K142789 |
| 510k Number | K142789 |
| Device Name: | A1c IGear System |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Sakae Corporation 239 ONISHI Fujioka, Gunma, JP 370-1401 |
| Contact | Shinji Nakayama |
| Correspondent | Erika B. Ammirati AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT Los Altos, CA 94022 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2014-12-16 |
| Summary: | summary |