510(k) K183573 ยท LYR Helicobacter Pylori
Vstrip H. pylori Antigen Rapid Test
| Applicant | Panion & BF Biotech, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, Mar 14, 2019 |
| Received | Dec 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183573
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.