510(k) K081276

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H by Horiba Abx — Product Code CFR

K081276 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H". The FDA issued a decision of Substantially Equivalent on September 12, 2008. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Horiba Abx has at least 10 other 510(k) clearances on record.