510(k) K073604

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD by Dade Behring, Inc. — Product Code CEC

K073604 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD". The FDA issued a decision of Substantially Equivalent on March 13, 2008. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.