510(k) K070820

ARCHITECT TACROLIMUS: MODEL 1L77 by Fujirebio Diagnostics,Inc. — Product Code MLM

K070820 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ARCHITECT TACROLIMUS: MODEL 1L77". The FDA issued a decision of Substantially Equivalent on August 1, 2007. The device falls under product code MLM (Enzyme Immunoassay, Tracrolimus), a Class II device regulated under 21 CFR 862.1678. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.