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510(k) K984567

VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) by Ventana, Inc. — Product Code MYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1999
Date Received
December 23, 1998
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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