FDA Product Code JLW: Radioimmunoassay, Thyroid-stimulating Hormone
Thyroid-stimulating hormone measurement is the primary screening test for thyroid dysfunction. FDA product code JLW covers radioimmunoassay systems for TSH quantification.
These assays measure TSH levels in serum to screen for hypothyroidism and hyperthyroidism, monitor thyroid hormone replacement therapy, and evaluate pituitary-thyroid axis function. TSH radioimmunoassays were the precursors to modern immunometric assays used today.
JLW devices are Class II medical devices, regulated under 21 CFR 862.1690 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Siemens Healthcare Diagnostics, Inc., Beckman Coulter, Inc. and Siemens Healthcare Diagnostics.
List of Radioimmunoassay, Thyroid-stimulating Hormone devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Radioimmunoassay, Thyroid-stimulating Hormone devices (product code JLW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →