510(k) K220494 ยท MSQ Test, Urea (Breath Or Blood)
BreathID Hp Lab System, BreathID Smart System
| Applicant | Meridian Bioscience Israel , Ltd., Modiin, IL |
| Decision | Substantially Equivalent, Jun 23, 2022 |
| Received | Feb 22, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220494
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.