510(k) K053612

DRI-STAT ACID PHOSPHATASE REAGENT by Beckman Coulter, Inc. — Product Code CKB

K053612 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "DRI-STAT ACID PHOSPHATASE REAGENT". The FDA issued a decision of Substantially Equivalent on April 26, 2006. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.