510(k) K961824

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN by Roche Diagnostic Systems, Inc. — Product Code DCF

K961824 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN". The FDA issued a decision of Substantially Equivalent on July 23, 1996. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.