510(k) K191578 ยท QFO Zika Virus Serological Reagents
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 17, 2019 |
| Received | Jun 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191578
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.