510(k) K130524 ยท MSQ Test, Urea (Breath Or Blood)
BREATHID HP SYSTEM
| Applicant | Exalenz Bioscience , Ltd., Wheat Ridge CO, US |
| Decision | Substantially Equivalent, May 22, 2013 |
| Received | Feb 28, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130524
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.