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Vysis

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN040010VYSIS AUTOVYSION SYSTEMDecember 13, 2004
K033982MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTJanuary 22, 2004
K013785UROVYSION BLADDER CANCER RECURRENCE KITFebruary 8, 2002
K011031VYSIS UROVYSION BLADDER CANCER RECURRENCE KITAugust 3, 2001
K010288ANEUVYSION MULITICOLOR DNA PROBE KITApril 13, 2001
K972200ANEUVYSIONOctober 20, 1997
K954214CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITJanuary 21, 1997
K962873CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBEJanuary 13, 1997
K953591CEP 8 SPECTRUMORANGE DNA PROBE KITNovember 29, 1996