510(k) K162150 ยท MSQ Test, Urea (Breath Or Blood)
BreathID Hp Lab System
| Applicant | Exalenz Bioscience , Ltd., Modiin, IL |
| Decision | Substantially Equivalent, Oct 31, 2016 |
| Received | Aug 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162150
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.