Imx Ultrasentitive Htsh

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

510(k) Number

K902753 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Lifeshield Extension Set

  Class II

  FDA 510(k) K941214 Active Cleared 3 Oct 1994

• Abbott Imx Prolactin(Modification)

  Class I

  FDA 510(k) K953656 Active Cleared 3 Oct 1995

• Ca

  Class II

  FDA 510(k) K981232 Active Cleared 18 May 1998

• Imx Folate

  Class II

  FDA 510(k) K943691 Active Cleared 23 Mar 1995

• Albp

  Class II

  FDA 510(k) K981457 Active Cleared 27 May 1998

• Axsym Gentamicin

  Class II

  FDA 510(k) K935376 Active Cleared 21 Jun 1994

See all devices from Abbott Mfg., Inc. →

• What is the IMX ULTRASENTITIVE HTSH used for?

  The IMX ULTRASENTITIVE HTSH is a radioimmunoassay designed to measure thyroid-stimulating hormone (TSH) levels in clinical chemistry settings. It is intended for in vitro diagnostic use to assess thyroid function by quantifying TSH in patient samples.

• How is the IMX ULTRASENTITIVE HTSH supplied and is it sterile or single-use?

  The device is supplied for in vitro diagnostic use in clinical laboratories. The provided data does not specify whether it is sterile, single-use, or reusable, so users should consult the manufacturer's labeling for details on handling, storage, and intended use format.

• What regulatory clearance does the IMX ULTRASENTITIVE HTSH have?

  The IMX ULTRASENTITIVE HTSH received FDA 510(k) clearance under submission K902753 on July 10, 1990. It is classified as a Class II medical device under regulation 862.1690 with product code JLW, and was determined to be substantially equivalent to a predicate device.