510(k) K782041

FIAX TEST KIT by Idt, A Division of Whittaker M.A. Bioproducts — Product Code DHN

K782041 is an FDA 510(k) premarket notification submitted by Idt, A Division of Whittaker M.A. Bioproducts for the device "FIAX TEST KIT". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Idt, A Division of Whittaker M.A. Bioproducts has at least 4 other 510(k) clearances on record.