Device Classification Name |
Immunohistochemistry Assay, Antibody, Progesterone Receptor
|
510(k) Number |
K012960 |
Device Name |
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR |
Applicant |
BIOGENEX LABORATORIES |
4600 NORRIS CANYON RD. |
SAN RAMON,
CA
94583
|
|
Applicant Contact |
GURVINDER S NANDA |
Correspondent |
BIOGENEX LABORATORIES |
4600 NORRIS CANYON RD. |
SAN RAMON,
CA
94583
|
|
Correspondent Contact |
GURVINDER S NANDA |
Regulation Number | 864.1860
|
Classification Product Code |
|
Date Received | 09/04/2001 |
Decision Date | 03/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|