510(k) K090939

ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 by Roche Diagnostics — Product Code DKB

K090939 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190". The FDA issued a decision of Substantially Equivalent on June 18, 2009. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Roche Diagnostics has at least 10 other 510(k) clearances on record.