510(k) K993281

K-ASSAY IGG by Kamiya Biomedical Co. — Product Code DEW

K993281 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY IGG". The FDA issued a decision of Substantially Equivalent on November 9, 1999. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.