Device Classification Name |
dna-probe kit, human chromosome
|
510(k) Number |
K972200 |
Device Name |
ANEUVYSION |
Applicant |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
RUSSEL K EVANS |
Correspondent |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
RUSSEL K EVANS |
Regulation Number | 866.4700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/10/1997 |
Decision Date | 10/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|