Data / Medical devices / Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (KLI): 32 FDA-registered makers in 12 countries

32 establishments in 12 countries are registered with the FDA to make Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (product code KLI, Class 2, 21 CFR 862.1700). 15 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 86 510(k) clearances under this code, the latest on October 18, 2016, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

KLI

Device class

2

Regulation

862.1700

Medical specialty

Clinical Chemistry

Makers by country

Makers of Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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 October 18, 2016. 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.