510(k) K760942

GENTASAK by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code DKD

K760942 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "GENTASAK". The FDA issued a decision of Substantially Equivalent on March 7, 1977. The device falls under product code DKD (Bacillus Subtilis, Microbiological Assay, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.