510(k) K895994 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
| Applicant | Lipogen, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Oct 24, 1989 |
| Received | Oct 13, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895994
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.