510(k) K061412

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 by Thermo Electron Corp. — Product Code JFY

K061412 is an FDA 510(k) premarket notification submitted by Thermo Electron Corp. for the device "THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401". The FDA issued a decision of Substantially Equivalent on March 23, 2007. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Thermo Electron Corp. has at least 9 other 510(k) clearances on record.