Vysis is one of 14076 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Vysis - FDA 510(k) Cleared Devices
Recent clearances: ANEUVYSION, CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT, CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
9
Total
8
Cleared
1
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
Not Cleared
Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
Pathology
61d
Cleared
Jan 22, 2004
MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
Immunology
30d
Cleared
Feb 08, 2002
UROVYSION BLADDER CANCER RECURRENCE KIT
Immunology
86d
Cleared
Aug 03, 2001
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
Immunology
120d
Cleared
Apr 13, 2001
ANEUVYSION MULITICOLOR DNA PROBE KIT
Pathology
72d
Cleared
Oct 20, 1997
ANEUVYSION
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