510(k) K070146

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP by Horiba Abx — Product Code CDQ

K070146 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP". The FDA issued a decision of Substantially Equivalent on October 12, 2007. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Horiba Abx has at least 10 other 510(k) clearances on record.