The following data is part of a premarket notification filed by Vivachek Biotech (hangzhou) Co., Ltd with the FDA for Vivachek Blood Glucose And B-ketone Monitoring System.
| Device ID | K192957 |
| 510k Number | K192957 |
| Device Name: | VivaChek Blood Glucose And B-Ketone Monitoring System |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou, CN 311100 |
| Contact | Mark Qian |
| Correspondent | Mark Qian Vivachek Biotech (Hangzhou) Co., Ltd 1/2/3 F, Building 1, 16 East Zhenxing Rd., Yuhang Hangzhou, CN 311100 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-21 |
| Decision Date | 2020-06-05 |