510(k) K950716 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
THERATEST EL-ANA PROFILES TEST SYSTEM
| Applicant | Theratest Laboratories, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Sep 26, 1995 |
| Received | Jan 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950716
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.