510(k) K100790

COULTER LIN-X LINEARITY CONTROL, MODEL A81196 by Beckman Coulter, Inc. — Product Code JPK

K100790 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "COULTER LIN-X LINEARITY CONTROL, MODEL A81196". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.