510(k) K041231 ยท NOP Elisa, Antibody, West Nile Virus
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
| Applicant | Panbio Limited, Windsor, AU |
| Decision | Substantially Equivalent, Aug 10, 2004 |
| Received | May 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2012 | Inverness Medical West Nile Virus IgM Capture ELISA
The Panbio West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical lab Terminated |
NOP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.