510(k) K053072

N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN by Dade Behring, Inc. — Product Code DEM

K053072 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN". The FDA issued a decision of Substantially Equivalent on March 28, 2006. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.