510(k) K073309

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT by Horiba Abx — Product Code LCP

K073309 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT". The FDA issued a decision of Substantially Equivalent on October 17, 2008. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Horiba Abx has at least 10 other 510(k) clearances on record.