510(k) K150962 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
| Applicant | Focus Diagnostics, Cypress CA, US |
| Decision | Substantially Equivalent, Aug 28, 2015 |
| Received | Apr 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | DiaSorin Molecular LLC MOL2150 Simplexa HSV 1&2 Direct
-CSF
-Genital Swab
-Cutaneous / Mucocutaneous Swabs
Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation o Terminated |
OQO | None listed |
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2150, MOL1451, MOL1452, MOL1455 Terminated |
PGH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.