Data / Medical devices / Radioimmunoassay, Thyroid-Stimulating Hormone

Radioimmunoassay, Thyroid-Stimulating Hormone (JLW): 47 FDA-registered makers in 12 countries

47 establishments in 12 countries are registered with the FDA to make Radioimmunoassay, Thyroid-Stimulating Hormone (product code JLW, Class 2, 21 CFR 862.1690). 30 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 242 510(k) clearances under this code, the latest on February 6, 2026, and lists 31 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

JLW

Device class

2

Regulation

862.1690

Medical specialty

Clinical Chemistry

Makers by country

Makers of Radioimmunoassay, Thyroid-Stimulating Hormone

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated February 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.