510(k) K771583

FLUORESCENT ANTI. ANTI-HUMAN C3 by Burroughs Wellcome Co. — Product Code DAC

K771583 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "FLUORESCENT ANTI. ANTI-HUMAN C3". The FDA issued a decision of Substantially Equivalent on September 2, 1977. The device falls under product code DAC (Complement C3b Activator, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5260. Burroughs Wellcome Co. has at least 10 other 510(k) clearances on record.