510(k) K000196 ยท DDR Myoglobin, Antigen, Antiserum, Control
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Feb 18, 2000 |
| Received | Jan 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000196
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.