510(k) K002974

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL by Dade Behring, Inc. — Product Code LDP

K002974 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL". The FDA issued a decision of Substantially Equivalent on October 11, 2000. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.