510(k) K120986 ยท OYP Anti-Jcv Antibody Detection Assay
STRATIFY JCV DXSELECT
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Aug 16, 2012 |
| Received | Apr 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120986
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2015 | Focus Diagnostics Inc STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic. Terminated |
OYP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.