510(k) K962452 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
| 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 K962452
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.