510(k) K011668 ยท MSQ Test, Urea (Breath Or Blood)
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
| Applicant | Oridion Medical 1987 , Ltd., Jerusalem, IL |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | May 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011668
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.