510(k) K212769 ยท OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
DYNEX SmartPLEX MMRV IgG Assay Kit
| Applicant | Dynex Technologies, Inc., Chantilly VA, US |
| Decision | Substantially Equivalent, Sep 29, 2023 |
| Received | Aug 31, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212769
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.