510(k) K051890

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO by Roche Diagnostics Corp. — Product Code JZO

K051890 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO". The FDA issued a decision of Substantially Equivalent on August 4, 2005. 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.