510(k) K063798 ยท GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
| Applicant | Diagnostic Hybrids, Inc., Athens OH, US |
| Decision | Substantially Equivalent, Sep 21, 2007 |
| Received | Dec 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063798
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.