510(k) K081928 ยท LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, Dec 23, 2008 |
| Received | Jul 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081928
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.