510(k) K202644

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

K202644 is an FDA 510(k) premarket notification submitted by Sekisui Diagnostics P.E.I., Inc. for the device "Acetaminophen". The FDA issued a decision of Substantially Equivalent on February 18, 2022. 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.