510(k) K024031 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
| Applicant | Theratest Laboratories, Inc., Lombard IL, US |
| Decision | Substantially Equivalent, Feb 6, 2003 |
| Received | Dec 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024031
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.