510(k) K160650 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
LIAISON HAV IgM, LIAISON Control HAV IgM
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Mar 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160650
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.