510(k) K864565 ยท GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Feb 19, 1987 |
| Received | Nov 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864565
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.