Cleared Traditional

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

K193393 · Leica Biosystems Newcastle, Ltd. · Pathology
Mar 2020
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K193393 is an FDA 510(k) clearance for the BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format)., a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Leica Biosystems Newcastle, Ltd. (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on March 6, 2020, 91 days after receiving the submission on December 6, 2019. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K193393 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2019
Decision Date March 06, 2020
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

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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