510(k) K181464 ยท LYR Helicobacter Pylori
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Aug 31, 2018 |
| Received | Jun 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181464
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.