510(k) K861379 ยท LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
| Applicant | Serono Diagnostics, Inc., Norwell MA, US |
| Decision | Substantially Equivalent, Jul 16, 1986 |
| Received | Apr 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861379
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.