510(k) K980076 ยท LYR Helicobacter Pylori
PREMIER PLATINUM HPSA
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Jan 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980076
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.