510(k) K935468 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
SYNELISA ANA TOTAL
| Applicant | Elias U.S.A., Inc., Osceola WI, US |
| Decision | Substantially Equivalent, Mar 25, 1994 |
| Received | Nov 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935468
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.