510(k) K915850 ยท DDR Myoglobin, Antigen, Antiserum, Control
OPUS MYOGLOBIN TEST SYSTEM
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Mar 17, 1992 |
| Received | Dec 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915850
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.