510(k) K992918

STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I by OraSure Technologies, Inc. — Product Code DKZ

K992918 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I". The FDA issued a decision of Substantially Equivalent on April 3, 2000. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.