510(k) K893753

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LHK

K893753 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code LHK (Antigen, Id, Candida Albicans), a Class II device regulated under 21 CFR 866.3165. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.