510(k) K851541 ยท DEW Igg, Antigen, Antiserum, Control
DART IMMUNOGLOBULINS REAGENT SYSTEM
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Jul 15, 1985 |
| Received | Apr 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851541
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.