510(k) K100853

COBAS 8000 MODULAR SERIES ANALYZER by Roche Diagnostics Corp. — Product Code DCF

K100853 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "COBAS 8000 MODULAR SERIES ANALYZER". The FDA issued a decision of Substantially Equivalent on September 9, 2010. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.