510(k) K801669

J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO by J.T. Baker Chemical Co. — Product Code DEM

K801669 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.