510(k) K071211

COBAS C 111 ANALYZER by Roche Diagnostics — Product Code CIT

K071211 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "COBAS C 111 ANALYZER". The FDA issued a decision of Substantially Equivalent on July 30, 2007. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Roche Diagnostics has at least 10 other 510(k) clearances on record.