510(k) K901805 ยท DAH Gamma Globulin, Antigen, Antiserum, Control
REP(R) IMMUNOFIX
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 6, 1990 |
| Received | Apr 20, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901805
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.