510(k) K051915 ยท DFH Kappa, Antigen, Antiserum, Control
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Sep 6, 2005 |
| Received | Jul 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051915
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.