510(k) K862969 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
| Applicant | Biohytech International, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Oct 24, 1986 |
| Received | Aug 6, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862969
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.