510(k) K900072

IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 by General Biometrics, Inc. — Product Code LJM

K900072 is an FDA 510(k) premarket notification submitted by General Biometrics, Inc. for the device "IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2". The FDA issued a decision of Substantially Equivalent on January 24, 1990. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. General Biometrics, Inc. has at least 10 other 510(k) clearances on record.