510(k) K772219

FIAX TEST FOR ANTI-RUBELLA ANTIBODY by Idt, A Division of Whittaker M.A. Bioproducts — Product Code DHN

K772219 is an FDA 510(k) premarket notification submitted by Idt, A Division of Whittaker M.A. Bioproducts for the device "FIAX TEST FOR ANTI-RUBELLA ANTIBODY". The FDA issued a decision of Substantially Equivalent on January 20, 1978. 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.