510(k) K961508 ยท LYR Helicobacter Pylori
IMMUNOCARD H. PYLORI
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jan 21, 1997 |
| Received | Apr 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961508
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.