K-numberK183100
Device nameEstrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
ApplicantLeica Biosystems Newcastle, Limited
Product codeMYA
Device classClass II
Decision dateDec 7, 2018
DecisionSubstantially Equivalent
Regulation864.1860
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View the full FDA submission: accessdata.fda.gov

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