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FDA 510(k) Application Details - K183102
Device Classification Name
Immunohistochemistry Assay,Antibody,Progesterone Receptor
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510(K) Number
K183102
Device Name
Immunohistochemistry Assay,Antibody,Progesterone Receptor
Applicant
Leica Biosystems Newcastle Limited
Balliol Business Park West, Benton Lane
Newcastle Upon Tyne NE12 8EW GB
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Contact
Jeremy Allen
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Regulation Number
864.1860
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Classification Product Code
MXZ
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Date Received
11/07/2018
Decision Date
12/07/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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