Medical Device Manufacturer · US , Downers Grove , IL

Vysis - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1996

Recent clearances: MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST, UROVYSION BLADDER CANCER RECURRENCE KIT, VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

View 9 510(k) Devices ↓

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.

Vysis is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

FDA 510(k) Regulatory Record - Vysis

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