Vysis Urovysion Bladder Cancer Recurrence Kit

• • Terminated Z-0640-04 FDA Unclassified (pre-2012) ·initiated 19 Feb 2004

  Some of the control slides did not have adequate cells deposited upon their surface.

510(k) Number

K011031 ↗

FDA Product Code

MMW

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Urovysion Bladder Cancer Recurrence Kit

  Class II

  FDA 510(k) K013785 Active Cleared 8 Feb 2002

• Cep X Spectrumorange\y Spectrumgreen DNA Probe Kit

  Class II

  FDA 510(k) K954214 Active Cleared 21 Jan 1997

• Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration DNA Probe

  Class II

  FDA 510(k) K962873 Active Cleared 13 Jan 1997

• Vysis Autovysion System

  Class II

  FDA De Novo DEN040010 Active Cleared 13 Dec 2004 FDA 510(k)

• Cep 8 Spectrumorange DNA Probe Kit

  Class II

  FDA 510(k) K953591 Active Cleared 29 Nov 1996

• Modification to Vysis Urovysion Bladder Cancer Recurrence Test

  Class II

  FDA 510(k) K033982 Active Cleared 22 Jan 2004

See all devices from Vysis →