510(k) K080634 ยท DDG Transferrin, Antigen, Antiserum, Control
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Aug 11, 2008 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080634
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.