510(k) K000489

ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST by Helix Diagnostics, Inc. — Product Code LLL

K000489 is an FDA 510(k) premarket notification submitted by Helix Diagnostics, Inc. for the device "ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on April 5, 2000. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Helix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.