510(k) K801361

COMPLEMENT C4 NEPHELOMETRIC ASSAY by J.T. Baker Chemical Co. — Product Code DBI

K801361 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "COMPLEMENT C4 NEPHELOMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.