510(k) K882199 ยท LYR Helicobacter Pylori
CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
| Applicant | Auspharm Intl. , Ltd., North Merrick NY, US |
| Decision | Substantially Equivalent, Oct 6, 1988 |
| Received | May 25, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882199
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.