510(k) K894659 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
ANA ANTISERA CONTROL KIT
| Applicant | Lipogen, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Sep 21, 1989 |
| Received | Jul 24, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894659
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.