Vitek Immunodiagnostic Assay System

• • Terminated Z-2331-2018 FDA Class II ·initiated 9 Apr 2018

  Invalid calibration with low calibrator S1 while using the product.

510(k) Number

K921746 ↗

FDA Product Code

CGJ

Device Class

Class I

Regulation

21 CFR Part 862.1300

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vitek Immun Assay Sys(Vidas) Thyroi Stim Hor Assay

  Class II

  FDA 510(k) K921816 Active Cleared 18 Jun 1992

• Hemolab

  Class II

  FDA 510(k) K931992 Active Cleared 22 Dec 1994

• Vidas Creatine Kinase Mb Assay 30-421

  Class II

  FDA 510(k) K962549 Active Cleared 30 Aug 1996

• Vidas Rotavirus (Rtv) Assay

  Class I

  FDA 510(k) K972895 Active Cleared 3 Oct 1997

• Hemolab Silimat Reagent

  Class I

  FDA 510(k) K920001 Active Cleared 25 Sep 1992

• Vidas T Uptake

  Class II

  FDA 510(k) K935816 Active Cleared 22 Mar 1994

See all devices from Biomerieux Vitek, Inc. →