510(k) K083188 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Oct 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083188
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.