510(k) K182474

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL by Biosystems S.A. — Product Code JFJ

K182474 is an FDA 510(k) premarket notification submitted by Biosystems S.A. for the device "alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL". The FDA issued a decision of Substantially Equivalent on May 2, 2019. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Biosystems S.A. has at least 6 other 510(k) clearances on record.