510(k) K993481

K-ASSAY C4 by Kamiya Biomedical Co. — Product Code DBI

K993481 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY C4". The FDA issued a decision of Substantially Equivalent on November 29, 1999. The device falls under product code DBI (Complement C4, 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.