510(k) K842532 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
AMIZYME-ANA TEST KIT
| Applicant | Amico Lab, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 20, 1984 |
| Received | Jun 28, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842532
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.