510(k) K801282

J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA by J.T. Baker Chemical Co. — Product Code DFT

K801282 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA". The FDA issued a decision of Substantially Equivalent on June 30, 1980. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.