510(k) K061775

WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR by Wako Chemicals USA, Inc. — Product Code JFY

K061775 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on February 23, 2007. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.