510(k) K080092

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB by Roche Diagnostics Corp. — Product Code JZO

K080092 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB". The FDA issued a decision of Substantially Equivalent on July 28, 2008. 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.