510(k) K955799 ยท LJO Antigen, Iha, Cytomegalovirus
COPALIS CMV TOTAL ANTIBODY ASSAY
| Applicant | Sienna Biotech, Inc., Bethesda MD, US |
| Decision | Substantially Equivalent, Jul 10, 1996 |
| Received | Dec 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955799
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.