510(k) K915428

KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT by Kronus — Product Code JZO

K915428 is an FDA 510(k) premarket notification submitted by Kronus for the device "KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT". The FDA issued a decision of Substantially Equivalent on March 30, 1992. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Kronus has at least 8 other 510(k) clearances on record.