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FDA 510(k) Application Details - K110215
Device Classification Name
Immunohistochemistry Antibody Assay, Estrogen Receptor
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510(K) Number
K110215
Device Name
Immunohistochemistry Antibody Assay, Estrogen Receptor
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755 US
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Contact
ROXANE BONNER
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Regulation Number
864.1860
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Classification Product Code
MYA
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Date Received
12/29/2010
Decision Date
12/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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