510(k) K926245

ABBOTT VISION THEOPHYLLINE IIA by Abbott Laboratories — Product Code KLS

K926245 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT VISION THEOPHYLLINE IIA". The FDA issued a decision of Substantially Equivalent on May 6, 1993. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Abbott Laboratories has at least 10 other 510(k) clearances on record.