510(k) K090760

THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 by Theratest Laboratories, Inc. — Product Code JZO

K090760 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120". The FDA issued a decision of Substantially Equivalent on September 3, 2009. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.