510(k) K953016

AXSYM THEOPHYLLINE II by Abbott Laboratories — Product Code LGS

K953016 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM THEOPHYLLINE II". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Abbott Laboratories has at least 10 other 510(k) clearances on record.