510(k) K002375

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I by OraSure Technologies, Inc. — Product Code LDJ

K002375 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I". The FDA issued a decision of Substantially Equivalent on January 26, 2001. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.