Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D

• • Terminated Z-1118-04 FDA Unclassified (pre-2012) ·initiated 30 Jun 2004 ·via K012367, on the same 510(k)

  Lower than expected results are obtained.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K012367 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

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

• 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

• 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 →