510(k) K993437

K-ASSAY C3 by Kamiya Biomedical Co. — Product Code CZW

K993437 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY C3". The FDA issued a decision of Substantially Equivalent on November 24, 1999. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.