Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody For Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra

Immunohistochemistry Antibody Assay, Estrogen Receptor

Leica Biosystems Newcastle Limited

The following data is part of a premarket notification filed by Leica Biosystems Newcastle Limited with the FDA for Estrogen Receptor Clone 6f11 Ready-to-use Primary Antibody For Bond, Estrogen Receptor Clone 6f11 Liquid Concentrate Primary Antibody, Novocastra.

Pre-market Notification Details

Device IDK183100
510k NumberK183100
Device Name:Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody For Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
ClassificationImmunohistochemistry Antibody Assay, Estrogen Receptor
Applicant Leica Biosystems Newcastle Limited Balliol Business Park West, Benton Lane Newcastle Upon Tyne,  GB Ne12 8ew
ContactJeremy Allen
CorrespondentZhijun (julie) Pan
Leica Biosystems Inc. 38 Cherry Hill Drive Danvers,  MA  01923
Product CodeMYA  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-07
Decision Date2018-12-07

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