510(k) K002559 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
EL-ANA PROFILES-2K1
| Applicant | Theratest Laboratories, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 12, 2000 |
| Received | Aug 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002559
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.