510(k) K151792

Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System by Siemens Healthcare Diagnostics, Inc. — Product Code JLW

K151792 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System". The FDA issued a decision of Substantially Equivalent on November 20, 2015. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.