FDA 510(k) Applications Submitted by VYSIS

FDA 510(k) Number Submission Date Device Name Applicant
K033982 12/23/2003 MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST VYSIS
DEN040010 10/13/2004 VYSIS AUTOVYSION SYSTEM VYSIS
K010288 01/31/2001 ANEUVYSION MULITICOLOR DNA PROBE KIT VYSIS
K011031 04/05/2001 VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT VYSIS
K962873 07/23/1996 CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE VYSIS
K013785 11/14/2001 UROVYSION BLADDER CANCER RECURRENCE KIT VYSIS
K972200 06/10/1997 ANEUVYSION VYSIS
K953591 08/01/1995 CEP 8 SPECTRUMORANGE DNA PROBE KIT VYSIS
K954214 09/07/1995 CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT VYSIS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact