Submission Details
| 510(k) Number | K192957 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VivaChek Blood Glucose and B-Ketone Monitoring System
Jun 2020
Decision
228d
Days
Class 1
Risk
About This 510(k) Submission
K192957 is an FDA 510(k) clearance for the VivaChek Blood Glucose and B-Ketone Monitoring System, 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 review panel. Regulated under 21 CFR 862.1435.
Device Classification
| Product Code | JIN — Nitroprusside, Ketones (urinary, Non-quant.) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1435 |
Manufacturer
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