510(k) K173327 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
DIP/U.S. Urine Analysis Test System
| Applicant | Healthy.Io, Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Jul 18, 2018 |
| Received | Oct 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173327
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.