510(k) K965213 ยท DDR Myoglobin, Antigen, Antiserum, Control
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Dec 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965213
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.