510(k) K033009

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 by Roche Diagnostics Corp. — Product Code CIX

K033009 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2". The FDA issued a decision of Substantially Equivalent on October 16, 2003. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.