510(k) K905409 ยท LYR Helicobacter Pylori
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
| Applicant | E-Z-Em, Inc., North Caldwell NJ, US |
| Decision | Substantially Equivalent, Jun 10, 1991 |
| Received | Dec 3, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905409
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.