510(k) K081938

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 by Genzyme Diagnostics P.E.I., Inc. — Product Code LDP

K081938 is an FDA 510(k) premarket notification submitted by Genzyme Diagnostics P.E.I., Inc. for the device "ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30". The FDA issued a decision of Substantially Equivalent on May 1, 2009. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Genzyme Diagnostics P.E.I., Inc. has at least 1 other 510(k) clearance on record.