510(k) K993354

K-ASSAY APO B by Kamiya Biomedical Co. — Product Code DER

K993354 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY APO B". The FDA issued a decision of Substantially Equivalent on October 28, 1999. The device falls under product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5580. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.