Medical Device Manufacturer · US , Downers Grove , IL

Vysis - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1996

Total

Cleared

Denied

Vysis has 8 FDA 510(k) cleared medical devices. Based in Downers Grove, US.

Historical record: 8 cleared submissions from 1996 to 2004. Primary specialty: Pathology.

Browse the FDA 510(k) cleared devices submitted by Vysis Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Vysis

9 devices

1-9 of 9

Not Cleared Dec 13, 2004

VYSIS AUTOVYSION SYSTEM

DEN040010 · NTH

Pathology · 61d

Cleared Jan 22, 2004

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

K033982 · MMW

Immunology · 30d

Cleared Feb 08, 2002

UROVYSION BLADDER CANCER RECURRENCE KIT

K013785 · MMW

Immunology · 86d

Cleared Aug 03, 2001

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

K011031 · MMW

Immunology · 120d

Cleared Apr 13, 2001

ANEUVYSION MULITICOLOR DNA PROBE KIT

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

K954214 · OXP

Pathology · 502d

Cleared Jan 13, 1997

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

K962873 · OVQ

Pathology · 174d

Cleared Nov 29, 1996

CEP 8 SPECTRUMORANGE DNA PROBE KIT

K953591 · OYU

Pathology · 486d

Vysis - FDA 510(k) Cleared Devices

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