510(k) K982866

NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 by Nichols Institute Diagnostics — Product Code JZO

K982866 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.