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
|
|
Correspondent Contact |
KERRY J FLOM |
Regulation Number | 866.6010
|
Classification Product Code |
|
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
|
|
|