510(k) K062180

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP by Horiba Abx — Product Code JFJ

K062180 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP". The FDA issued a decision of Substantially Equivalent on October 2, 2006. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Horiba Abx has at least 10 other 510(k) clearances on record.