510(k) K150412 ยท DAE Complement C9, Antigen, Antiserum, Control
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Aug 28, 2015 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150412
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.