Chemiluminescence Lh

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935319 ↗

FDA Product Code

CEP

Device Class

Class I

Regulation

21 CFR Part 862.1485

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay

  Class II

  FDA 510(k) K042676 Active Cleared 17 Dec 2004

• Nichols Apo B Chemiluminescence Assay

  Class I

  FDA 510(k) K925702 Active Cleared 23 Dec 1992

• Advantage Chemiluminescence Erythropoietin Immunoassay

  Class II

  FDA 510(k) K980737 Active Cleared 23 Mar 1999

• Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D

  Class II

  FDA 510(k) K012367 Active Cleared 9 Oct 2001

• Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone

  Class II

  FDA 510(k) K962601 Active Cleared 24 Dec 1996

• Aminoglycoside Test System

  Class II

  FDA 510(k) K780048 Active Cleared 20 Jan 1978

See all devices from Quest Diagnostics Nichols Institute →