510(k) K954700 ยท LKJ Antinuclear Antibody, Antigen, Control
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Dec 15, 1995 |
| Received | Oct 12, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954700
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.