510(k) K050625 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
VARELISA RECOMBI ANA PROFILE, MODEL 18496
| Applicant | Sweden Diagnostics (Germany) GmbH, Freiburg, DE |
| Decision | Substantially Equivalent, Apr 26, 2005 |
| Received | Mar 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050625
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.