510(k) K023009 ยท DFH Kappa, Antigen, Antiserum, Control
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Jan 21, 2003 |
| Received | Sep 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023009
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.