510(k) K082759 ยท LKJ Antinuclear Antibody, Antigen, Control
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Apr 10, 2009 |
| Received | Sep 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082759
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.