ClearanceBrief
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

ApplicantDiagnostic Hybrids, Inc., Athens OH, US
DecisionSubstantially Equivalent, Sep 21, 2007
ReceivedDec 22, 2006
TypeTraditional
FDA recordOpen 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.