510(k) K123785 ยท DDR Myoglobin, Antigen, Antiserum, Control
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Jun 7, 2013 |
| Received | Dec 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123785
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.