510(k) K954895 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
HYTEC AUTOIMMUNE KIT (JO-1)
| Applicant | Hycor Biomedical, Inc., Garden Grove CA, US |
| Decision | Substantially Equivalent, Mar 20, 1996 |
| Received | Oct 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954895
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.