510(k) K862299

AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS by Amresco, Inc. — Product Code CIG

K862299 is an FDA 510(k) premarket notification submitted by Amresco, Inc. for the device "AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS". The FDA issued a decision of Substantially Equivalent on July 1, 1986. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Amresco, Inc. has at least 10 other 510(k) clearances on record.