510(k) K180835

SEKURE Acetaminophen L3K Assay by Sekisui Diagnostics P.E.I., Inc. — Product Code LDP

K180835 is an FDA 510(k) premarket notification submitted by Sekisui Diagnostics P.E.I., Inc. for the device "SEKURE Acetaminophen L3K Assay". The FDA issued a decision of Substantially Equivalent on February 8, 2019. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Sekisui Diagnostics P.E.I., Inc. has at least 5 other 510(k) clearances on record.