510(k) K200506 ยท QFO Zika Virus Serological Reagents
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader
| Applicant | Chembio Diagnostic Systems, Medford NY, US |
| Decision | Substantially Equivalent, Jun 3, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200506
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.