Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra— 510(k) K183100

Substantially Equivalent

Leica Biosystems Newcastle, Limited

FDA 510(k) clearance K183100 for Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra, Substantially Equivalent on 2018-12-07. Applicant: Leica Biosystems Newcastle, Limited. Device class: 2.

Clearance details

Applicant
Leica Biosystems Newcastle, Limited
Product code
Code MYA
Device class
Class 2
Regulation
21 CFR 864.1860
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Newcastle Upon Tyne, GB
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