510(k) K833119

AUTOIMMUNE TEST 1/2/3 SYSTEM by Atlantic Antibodies — Product Code DHN

K833119 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "AUTOIMMUNE TEST 1/2/3 SYSTEM". The FDA issued a decision of Substantially Equivalent on November 21, 1983. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Atlantic Antibodies has at least 10 other 510(k) clearances on record.