510(k) K962450 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
| Applicant | Hycor Biomedical, Inc., Garden Grove CA, US |
| Decision | Substantially Equivalent, Nov 25, 1996 |
| Received | Jun 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962450
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.