510(k) K161139 ยท LYR Helicobacter Pylori
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Jul 22, 2016 |
| Received | Apr 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161139
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.