Neonatal TSH RIA Kit (125I)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K772192 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Neonatal TSH RIA Kit (125I) used for?

  The Neonatal TSH RIA Kit (125I) is used for measuring thyroid-stimulating hormone (TSH) in neonatal specimens. It is a radioimmunoassay device designed specifically for this clinical chemistry application in newborn screening.

• How is the Neonatal TSH RIA Kit (125I) supplied and what is its intended use?

  The device is supplied as a radioimmunoassay kit for in vitro diagnostic use. It is intended to measure TSH levels in neonatal blood samples to assist in the detection of congenital hypothyroidism, based on its cleared intended use as a Class 2 clinical chemistry device.

• What regulatory pathway was used for the Neonatal TSH RIA Kit (125I) and what is its classification?

  The Neonatal TSH RIA Kit (125I) was cleared through the FDA's traditional 510(k) pathway under submission K772192 on January 12, 1978. It is classified as a Class 2 device under the Clinical Chemistry medical specialty with product code JLW.