Corning's Magic T3 (125I) Radioimmunoassay

No FDA recalls on record, checked 22 Oct 2026.

Full name

Corning's Magic T3(125I) Radioimmuno-

510(k) Number

K832353 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Corning Medical & Scientific →

• What is the primary clinical use of the Corning Magic T3 (125I) Radioimmunoassay?

  This device is designed for the quantitative analysis of total triiodothyronine in patient samples. It functions as a clinical chemistry tool to measure this specific hormone level.

• What is the regulatory status of this device?

  The device is regulated under FDA 510(k) clearance number K832353. It is classified as a Class 2 medical device under regulation number 862.1710.

• What technology does this device use to measure hormone levels?

  The device utilizes radioimmunoassay technology to perform its quantitative measurements. This method is specifically applied to the analysis of total triiodothyronine.