510(k) K060502

DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 by Dade Behring, Inc. — Product Code MLM

K060502 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107". The FDA issued a decision of Substantially Equivalent on May 18, 2006. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.