510(k) K192957 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
VivaChek Blood Glucose and B-Ketone Monitoring System
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Jun 5, 2020 |
| Received | Oct 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192957
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.