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

Immunohistochemistry Assay, Antibody, Progesterone Receptor

Leica Biosystems Newcastle Ltd.

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

Pre-market Notification Details

Device IDK193393
510k NumberK193393
Device Name:BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
ClassificationImmunohistochemistry Assay, Antibody, Progesterone Receptor
Applicant Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane Newcastle Upon Tyne,  GB Ne12 8ew
ContactMatthew West
CorrespondentZhijun (julie) Pan
Leica Biosystems 38 Cherry Hill Drive Danvers,  MA  01923
Product CodeMXZ  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyHematology
510k Review PanelPathology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2020-03-06

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