510(k) K182384 ยท JFY Enzymatic Method, Creatinine
ACR LAB Urine Analysis Test System
| Applicant | Healthy.Io, Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Jul 26, 2019 |
| Received | Aug 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182384
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.