510(k) K120413 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Jul 13, 2012 |
| Received | Feb 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2014 | Focus Diagnostics Inc Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650.
510(k) K120413 Simplexa" Flu A/B & RSV Direct.
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Inte Terminated |
OCC | None listed |
| Jan 28, 2014 | Focus Diagnostics Inc Simplexa Flu A/B & RSV Direct assay, Model MOL2650.
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative d Terminated |
OCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.