510(k) K053426

ROCHE ELECSYS ANTI-TG by Roche Diagnostics Corp. — Product Code JZO

K053426 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE ELECSYS ANTI-TG". The FDA issued a decision of Substantially Equivalent on February 7, 2006. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.