Ariol Her-2/Neu Ihc

• • Terminated Z-1948-2016 FDA Class III ·initiated 6 May 2016 ·on shared 510(k) K031715

  An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K031715 ↗

FDA Product Code

NOT

Device Class

Class II

Regulation

21 CFR Part 864.1860

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Ariol Her-2/Neu Fish

  Class II

  FDA 510(k) K043519 Active Cleared 25 Apr 2005

• Ariol

  Class II

  FDA 510(k) K033200 Active Cleared 18 Mar 2004

• Winscan Automated Imaging System

  Class II

  FDA 510(k) K980375 Active Cleared 9 Jun 1998

• Genevision - Computer Assisted Chromosome Karyo.

  Class II

  FDA 510(k) K902311 Active Cleared 20 Aug 1990

• Slidescan

  Class II

  FDA 510(k) K001420 Active Cleared 30 Aug 2000

• Cytovision for Cep Xy

  Class II

  FDA 510(k) K042542 Active Cleared 10 Jan 2005