510(k) K140493 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ELIA SCL-70S IMMUNOASSAY
| Applicant | Phadia GmbH, Portage MI, US |
| Decision | Substantially Equivalent, Oct 30, 2014 |
| Received | Feb 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140493
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.