510(k) K193610 ยท MSQ Test, Urea (Breath Or Blood)
BreathID Smart System
| Applicant | Exalenz Bioscience , Ltd., Modiin, IL |
| Decision | Substantially Equivalent, Feb 6, 2020 |
| Received | Dec 26, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193610
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.