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510(k) K103818

CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY by Ventana Medical Sytems, Inc. — Product Code MXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2011
Date Received
December 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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