510(k) K993444

K-ASSAY ALPHA-1 AT by Kamiya Biomedical Co. — Product Code DEM

K993444 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY ALPHA-1 AT". The FDA issued a decision of Substantially Equivalent on November 24, 1999. The device falls under product code DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.