510(k) K934137 ยท MJX Kit, Serological, Positive Control
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Mar 7, 1994 |
| Received | Aug 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934137
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.