510(k) K840111

TOTAL BILIRUBIN by Fisher Scientific Co., LLC — Product Code CIG

K840111 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "TOTAL BILIRUBIN". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.