510(k) K874195 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LA ANTIBODY TEST KIT
| Applicant | Lipogen, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Mar 11, 1988 |
| Received | Oct 14, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874195
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.