510(k) K192046 ยท QFO Zika Virus Serological Reagents
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
| Applicant | DiaSorin, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Oct 28, 2019 |
| Received | Jul 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192046
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.