510(k) K080481 ยท DDR Myoglobin, Antigen, Antiserum, Control
ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 20, 2009 |
| Received | Feb 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080481
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.