510(k) K083465

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE by Siemens Healthcare Diagnostics — Product Code CGS

K083465 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on February 27, 2009. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.