Device Classification Name |
immunohistochemistry assay, antibody, progesterone receptor
|
510(k) Number |
K990618 |
Device Name |
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
3865 N. BUSINESS CENTER DR. |
TUCSON,
AZ
85705
|
|
Applicant Contact |
JUDITH FREDERICK |
Correspondent |
VENTANA MEDICAL SYSTEMS, INC. |
3865 N. BUSINESS CENTER DR. |
TUCSON,
AZ
85705
|
|
Correspondent Contact |
JUDITH FREDERICK |
Regulation Number | 864.1860
|
Classification Product Code |
|
Date Received | 02/25/1999 |
Decision Date | 07/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|