510(k) K951205 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
VARELISA ANA PROFILE
| Applicant | Elias U.S.A., Inc., Osceola WI, US |
| Decision | Substantially Equivalent, Apr 17, 1995 |
| Received | Mar 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951205
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.