510(k) K891683 ยท CZN Iga, Fitc, Antigen, Antiserum, Control
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 12, 1989 |
| Received | Mar 22, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891683
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.