510(k) K090330

DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 by Siemens Healthcare Diagnostics, Inc. — Product Code JFY

K090330 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270". The FDA issued a decision of Substantially Equivalent on May 22, 2009. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.