510(k) K081732

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS by Siemens Healthcare Diagnostics — Product Code DAP

K081732 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS". The FDA issued a decision of Substantially Equivalent on October 24, 2008. 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. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.