Cep 8 Spectrumorange DNA Probe Kit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K953591 ↗

FDA Product Code

OYU

Device Class

Class II

Regulation

21 CFR Part 866.4700

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

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  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)

• Modification to Vysis Urovysion Bladder Cancer Recurrence Test

  Class II

  FDA 510(k) K033982 Active Cleared 22 Jan 2004

• Vysis Urovysion Bladder Cancer Recurrence Kit

  Class II

  FDA 510(k) K011031 Active Cleared 3 Aug 2001

See all devices from Vysis →