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510(k) K122556

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) by Leica Biosystems Newcastle, Ltd. — Product Code MYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2014
Date Received
August 22, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

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