510(k) K770400

REAGENT, AMYLASE LIPASE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KHM

K770400 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "REAGENT, AMYLASE LIPASE". The FDA issued a decision of Substantially Equivalent on April 26, 1977. The device falls under product code KHM (Nephelometric, Amylase), a Class II device regulated under 21 CFR 862.1070. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.