510(k) K152061

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material by Siemens Healthcare Diagnostics, Inc. — Product Code JZO

K152061 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material". The FDA issued a decision of Substantially Equivalent on March 3, 2016. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.