510(k) K182038 ยท JFY Enzymatic Method, Creatinine
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
| Applicant | Yd Diagnostics Corporation, Yongin-Si, KR |
| Decision | Substantially Equivalent, Dec 10, 2018 |
| Received | Jul 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182038
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.