Device Classification Name |
System, Test, Tumor Marker, Monitoring, Bladder
|
510(k) Number |
K013785 |
Device Name |
UROVYSION BLADDER CANCER RECURRENCE KIT |
Applicant |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
RUSSEL K ENNS |
Correspondent |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
RUSSEL K ENNS |
Regulation Number | 866.6010
|
Classification Product Code |
|
Date Received | 11/14/2001 |
Decision Date | 02/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|