Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone

• • Terminated Z-1044-05 FDA Unclassified (pre-2012) ·initiated 22 Apr 2005

  Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.

510(k) Number

K962601 ↗

FDA Product Code

CKG

Device Class

Class II

Regulation

21 CFR Part 862.1025

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Nichols Apo B Chemiluminescence Assay

  Class I

  FDA 510(k) K925702 Active Cleared 23 Dec 1992

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  FDA 510(k) K980737 Active Cleared 23 Mar 1999

• Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D

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• Aminoglycoside Test System

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  FDA 510(k) K780048 Active Cleared 20 Jan 1978

• Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample Diluent)

  Class II

  FDA 510(k) K011128 Active Cleared 6 Sep 2001

See all devices from Quest Diagnostics Nichols Institute →