510(k) K913080 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
OPUS(R) ANTI CMV-M
| Applicant | Pb Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Oct 28, 1991 |
| Received | Jul 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913080
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.