Cleared Special

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

K171753 · Leica Biosystems Newcastle, Limited · Pathology
Jul 2017
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K171753 is an FDA 510(k) clearance for the BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16, a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Leica Biosystems Newcastle, Limited (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on July 21, 2017, 39 days after receiving the submission on June 12, 2017. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K171753 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2017
Decision Date July 21, 2017
Days to Decision 39 days
Submission Type Special
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.1860

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