510(k) K895822

TOTAL BILIRUBIN L.F. by Sclavo, Inc. — Product Code CIG

K895822 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "TOTAL BILIRUBIN L.F.". The FDA issued a decision of Substantially Equivalent on November 14, 1989. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Sclavo, Inc. has at least 10 other 510(k) clearances on record.