510(k) K040291 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
EL-ANA PROFILES: ANTI-CHROMATIN
| Applicant | Theratest Laboratories, Inc., Lombard IL, US |
| Decision | Substantially Equivalent, Mar 11, 2004 |
| Received | Feb 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040291
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.