Vidas Chlamydia Assay Vitek Immundiag Assay Syst

• • Terminated Z-3129-2011 FDA Unclassified (pre-2012) ·initiated 8 Jul 2011

  Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy being prescribed to patients.

510(k) Number

K905787 ↗

FDA Product Code

LJC

Device Class

Class I

Regulation

21 CFR Part 866.3120

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Ams Gram-Positive Ident. Card

  Class I

  FDA 510(k) K834389 Active Cleared 9 Mar 1984

• Vitek Immunodiagnostic Assay System (Vidas) (Rbg)

  Class II

  FDA 510(k) K902925 Active Cleared 9 Aug 1990

• Procainamide Calibrator Kit

  Class II

  FDA 510(k) K780732 Active Cleared 22 Nov 1978

• Vitek Immunodiag Assay Syst(Vidas) Ferritine Assay

  Class II

  FDA 510(k) K920952 Active Cleared 7 Apr 1992

• Vitek Immunodiagnostic Assay System

  Class II

  FDA 510(k) K921302 Active Cleared 28 Jul 1992

• Rapid Coryne Syst/Identif of Coryneform Bacteria

  Class I

  FDA 510(k) K910304 Active Cleared 26 Jul 1991

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