510(k) K153661 ยท LYR Helicobacter Pylori
ImmunoCard STAT! HpSA
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Mar 14, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153661
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.