510(k) K011289

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 by Syva Co., Dade Behring, Inc. — Product Code DJG

K011289 is an FDA 510(k) premarket notification submitted by Syva Co., Dade Behring, Inc. for the device "EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229". The FDA issued a decision of Substantially Equivalent on May 15, 2001. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Syva Co., Dade Behring, Inc. has at least 10 other 510(k) clearances on record.