510(k) K822682

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K by Amico Lab, Inc. — Product Code DHN

K822682 is an FDA 510(k) premarket notification submitted by Amico Lab, Inc. for the device "ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Amico Lab, Inc. has at least 10 other 510(k) clearances on record.