510(k) K050665

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) by Dade Behring, Inc. — Product Code CZW

K050665 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)". The FDA issued a decision of Substantially Equivalent on May 2, 2005. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.