510(k) K232892 · LYR Helicobacter Pylori
Hp Detect Stool Antigen ELISA
| Applicant | Biomerica, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 15, 2023 |
| Received | Sep 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232892
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.