Cleared Traditional

CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY

K103818 · Ventana Medical Sytems, Inc. · Pathology
Nov 2011
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K103818 is an FDA 510(k) clearance for the CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY, a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II — Special Controls, product code MXZ), submitted by Ventana Medical Sytems, Inc. (Tucson, US). The FDA issued a Cleared decision on November 16, 2011, 322 days after receiving the submission on December 29, 2010. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K103818 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2010
Decision Date November 16, 2011
Days to Decision 322 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

Similar Devices — MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

All 12
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. · Mar 2020
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K183102 · Leica Biosystems Newcastle, Limited · Dec 2018
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
K170005 · Dako Denmark A/S · Dec 2017
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
K171753 · Leica Biosystems Newcastle, Limited · Jul 2017
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
K160922 · Dako North America, Inc. · May 2016
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
K130861 · Dako North America, Inc. · Dec 2013