510(k) K951850

ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT by Helix Diagnostics, Inc. — Product Code LJM

K951850 is an FDA 510(k) premarket notification submitted by Helix Diagnostics, Inc. for the device "ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on July 18, 1995. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Helix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.