The following data is part of a premarket notification filed by Biohermes Co., Ltd with the FDA for A1c Ez Glycohemoglobin Analysis System.
| Device ID | K161533 |
| 510k Number | K161533 |
| Device Name: | A1C EZ Glycohemoglobin Analysis System |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BioHermes Co., Ltd 2F, 3F, No 136 Mashan Meiliang Road, Binhu Dist Wuxi, CN Js510 |
| Contact | Rao Qiangying |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. Room 2032, International Mayors Communication Ctr No. 55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2017-06-16 |
| Summary: | summary |