510(k) K831358 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
AUTOANTIBODY SCREEN TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 15, 1983 |
| Received | Apr 26, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831358
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.