510(k) K063356

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK by Dade Behring, Inc. — Product Code DAP

K063356 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK". The FDA issued a decision of Substantially Equivalent on March 23, 2007. 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. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.