510(k) K964385 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ELIAS ANA-HEP-2
| Applicant | Elias U.S.A., Inc., Osceola WI, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964385
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.