510(k) K954891 ยท LKJ Antinuclear Antibody, Antigen, Control
HYTEC AUTOIMMUNE KITS (SS-B)
| Applicant | Hycor Biomedical, Inc., Garden Grove CA, US |
| Decision | Substantially Equivalent, Dec 26, 1995 |
| Received | Sep 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954891
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.