510(k) K812253 ยท CZP Iga, Antigen, Antiserum, Control
GELMAN IG-FIX KIT
| Applicant | Gelman Sciences, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 1, 1981 |
| Received | Aug 11, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812253
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.