510(k) K190219 ยท PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, May 13, 2019 |
| Received | Feb 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190219
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | DiaSorin Molecular LLC MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patie Terminated |
PLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.