510(k) K052519 ยท NOP Elisa, Antibody, West Nile Virus
SPECTRAL WEST NILE VIRUS IGM STATUS TEST
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Nov 30, 2006 |
| Received | Sep 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052519
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.