K192957 is an FDA 510(k) clearance for the VivaChek Blood Glucose and B-Ketone Monitoring System. This device is classified as a Nitroprusside, Ketones (urinary, Non-quant.) (Class I - General Controls, product code JIN).
Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 5, 2020, 228 days after receiving the submission on October 21, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.
| 510(k) Number | K192957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2019 |
| Decision Date | June 05, 2020 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIN - Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1435 |