510(k) K033491

ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS by Roche Diagnostics Corp. — Product Code DAP

K033491 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS". The FDA issued a decision of Substantially Equivalent on September 1, 2004. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.