Cleared Traditional

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)

K061360 · Lab Vision Corp. · Pathology
Jun 2006
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K061360 is an FDA 510(k) clearance for the NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1), a Immunohistochemistry Antibody Assay, Estrogen Receptor (Class II — Special Controls, product code MYA), submitted by Lab Vision Corp. (Fremont, US). The FDA issued a Cleared decision on June 27, 2006, 42 days after receiving the submission on May 16, 2006. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1860.

Submission Details

510(k) Number K061360 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2006
Decision Date June 27, 2006
Days to Decision 42 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

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

Similar Devices — MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

All 11
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
K183100 · Leica Biosystems Newcastle, Limited · Dec 2018
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
K170028 · Dako Denmark A/S · Dec 2017
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · Leica Biosystems Newcastle, Ltd. · May 2014
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
K120663 · Dako North America, Inc. · Feb 2013
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · Ventana Medical Systems, Inc. · Dec 2012
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
K081286 · Dako North America, Inc. · May 2009