510(k) K892421 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
| Applicant | Lipogen, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, May 9, 1989 |
| Received | Apr 10, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892421
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.