510(k) K071002

IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT by Beckman Coulter, Inc. — Product Code NQD

K071002 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT". The FDA issued a decision of Substantially Equivalent on June 21, 2007. The device falls under product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.