510(k) K011878

EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL by Syva Co. — Product Code DKJ

K011878 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL". The FDA issued a decision of Substantially Equivalent on August 13, 2001. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Syva Co. has at least 10 other 510(k) clearances on record.