510(k) K894364

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) by Kronus — Product Code JZO

K894364 is an FDA 510(k) premarket notification submitted by Kronus for the device "MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)". The FDA issued a decision of Substantially Equivalent on July 25, 1989. 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.