510(k) K884596

ABBOTT A-GENT LIPASE REAGENT by Abbott Laboratories — Product Code CHI

K884596 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT A-GENT LIPASE REAGENT". The FDA issued a decision of Substantially Equivalent on December 6, 1988. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Abbott Laboratories has at least 10 other 510(k) clearances on record.