510(k) K230901 ยท LYR Helicobacter Pylori
Premier HpSA Flex (619096)
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 3, 2023 |
| Received | Mar 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230901
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.