510(k) K081193

COBAS INTEGRA 400/800 BILIRUBIN TOTAL by Roche Diagnostics — Product Code CIG

K081193 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "COBAS INTEGRA 400/800 BILIRUBIN TOTAL". The FDA issued a decision of Substantially Equivalent on January 16, 2009. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Roche Diagnostics has at least 10 other 510(k) clearances on record.