510(k) K954896 ยท LKP Anti-Sm Antibody, Antigen And Control
HYTEC AUTOIMMUNE KITS (SM)
| Applicant | Hycor Biomedical, Inc., Garden Grove CA, US |
| Decision | Substantially Equivalent, Mar 22, 1996 |
| Received | Sep 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954896
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.