510(k) K010441 ยท DEH Lambda, Antigen, Antiserum, Control
FREELITE KAPPA FREE KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Apr 26, 2001 |
| Received | Feb 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010441
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.