510(k) K081164 ยท LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, Jun 13, 2008 |
| Received | Apr 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081164
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.