510(k) K113349 ยท DAE Complement C9, Antigen, Antiserum, Control
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Jul 11, 2012 |
| Received | Nov 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113349
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.