510(k) K023807

MODIFICATION TO ALKP by Abbott Laboratories — Product Code CJE

K023807 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "MODIFICATION TO ALKP". The FDA issued a decision of Substantially Equivalent on December 26, 2002. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Abbott Laboratories has at least 10 other 510(k) clearances on record.