510(k) K932424 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANA PROFILE I
| Applicant | Apotex Scientific, Inc., Arlington TX, US |
| Decision | Substantially Equivalent, Aug 10, 1993 |
| Received | May 19, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932424
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.