510(k) K882740 ยท LKJ Antinuclear Antibody, Antigen, Control
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
| Applicant | Lipogen, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Sep 22, 1988 |
| Received | Jul 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882740
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.