510(k) K060205

GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER by Horiba Abx — Product Code CJE

K060205 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Horiba Abx has at least 10 other 510(k) clearances on record.