510(k) K073055

DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 by Dade Behring, Inc. — Product Code JFY

K073055 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270". The FDA issued a decision of Substantially Equivalent on January 3, 2008. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.