Medical Device Manufacturer · US , Downers Grove , IL

Vysis - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1996

9

Total

8

Cleared

1

Denied

FDA 510(k) Regulatory Record - Vysis Pathology ✕

6 devices

1-6 of 6

Not Cleared Dec 13, 2004

VYSIS AUTOVYSION SYSTEM

DEN040010 · NTH

Pathology · 61d

Cleared Apr 13, 2001

ANEUVYSION MULITICOLOR DNA PROBE KIT

Pathology · 72d

Cleared Oct 20, 1997

Pathology · 132d

Cleared Jan 21, 1997

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

Pathology · 502d

Cleared Jan 13, 1997

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

Pathology · 174d

Cleared Nov 29, 1996

CEP 8 SPECTRUMORANGE DNA PROBE KIT

Pathology · 486d