510(k) K950102

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT by Kent Laboratories, Inc. — Product Code DAY

K950102 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "HUMAN C-5 RADIAL IMMUNODIFFUSION KIT". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code DAY (Complement C5, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.