510(k) K011300

EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 by Syva Co., Dade Behring, Inc. — Product Code LDJ

K011300 is an FDA 510(k) premarket notification submitted by Syva Co., Dade Behring, Inc. for the device "EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229". The FDA issued a decision of Substantially Equivalent on May 17, 2001. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. Syva Co., Dade Behring, Inc. has at least 10 other 510(k) clearances on record.