BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16

Immunohistochemistry Assay, Antibody, Progesterone Receptor

Leica Biosystems Newcastle Limited

The following data is part of a premarket notification filed by Leica Biosystems Newcastle Limited with the FDA for Bond Ready-to-use (rtu) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16.

Pre-market Notification Details

Device IDK171753
510k NumberK171753
Device Name:BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
ClassificationImmunohistochemistry Assay, Antibody, Progesterone Receptor
Applicant Leica Biosystems Newcastle Limited Balliol Business Park West, Benton Lane Newcastle Upon Tyne,  GB Ne12 8ew
ContactBert Peerboom
CorrespondentCarol Adiletto-francis
Leica Biosystems Inc. 36 Cherry Hill Drive Danvers,  MA  09123
Product CodeMXZ  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-12
Decision Date2017-07-21

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