510(k) K053335 ยท LYR Helicobacter Pylori
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Mar 10, 2006 |
| Received | Dec 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053335
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.