MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST


Device Classification Name

system, test, tumor marker, monitoring, bladder

510(k) Number K033982
Device Name MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
Applicant
VYSIS
3100 woodcreek drive
downers grove, 
IL 
60515 -5400

Applicant Contact kerry j flom
Correspondent
VYSIS
3100 woodcreek drive
downers grove, 
IL 
60515 -5400

Correspodent Contact kerry j flom
Regulation Number 866.6010
Classification Product Code
MMW  
Date Received 12/23/2003
Decision Date 01/22/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No