Device Classification Name |
Immunohistochemistry Antibody Assay, Estrogen Receptor
|
510(k) Number |
K122556 |
Device Name |
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) |
Applicant |
LEICA BIOSYSTEMS NEWCASTLE LTD |
5205 Route 12 |
Richmond,
IL
60071
|
|
Applicant Contact |
BARBARA-ANN CONWAY-MAYERS |
Correspondent |
LEICA BIOSYSTEMS NEWCASTLE LTD |
5205 Route 12 |
Richmond,
IL
60071
|
|
Correspondent Contact |
BARBARA-ANN CONWAY-MAYERS |
Regulation Number | 864.1860
|
Classification Product Code |
|
Date Received | 08/22/2012 |
Decision Date | 05/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|