510(k) K031953 ยท NOP Elisa, Antibody, West Nile Virus
WEST NILE VIRUS ELISA IGG, MODEL EL0300G
| Applicant | Focus Technologies, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Oct 22, 2003 |
| Received | Jun 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031953
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2012 | Focus Diagnostics Inc West Nile Virus IgG DxSelect" kit Catalog No. EL0300G
Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen
Wells, Catalog Number EL0351, Lot Number 121117.
510 Terminated |
NOP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.