510(k) K791493

ANTI-NUCLEAR ANTIBODY TEST by Meloy Laboratories, Inc. — Product Code DHN

K791493 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "ANTI-NUCLEAR ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.