FDA Product Code MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor
Leading manufacturers include Dako North America, Inc., Leica Biosystems Newcastle, Ltd. and Dako Denmark A/S.
12
Total
12
Cleared
295d
Avg days
1999
Since
FDA 510(k) Cleared Immunohistochemistry Antibody Assay, Estrogen Receptor Devices (Product Code MYA)
12 devices
Cleared
Dec 07, 2018
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
Leica Biosystems Newcastle, Limited
Pathology
30d
Cleared
Dec 21, 2017
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
Dako Denmark A/S
Pathology
352d
Cleared
May 19, 2014
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Leica Biosystems Newcastle, Ltd.
Pathology
635d
Cleared
Feb 12, 2013
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
Dako North America, Inc.
Pathology
344d
Cleared
Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
Ventana Medical Systems, Inc.
Pathology
719d
Cleared
May 08, 2009
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
Dako North America, Inc.
Pathology
366d
Cleared
Jun 27, 2006
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
Lab Vision Corp.
Pathology
42d
Cleared
May 25, 2006
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Vision Biosystems, Inc.
Pathology
115d
Cleared
Sep 30, 2002
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
Chroma Vision Medical Systems, Inc.
Pathology
447d
Cleared
Feb 28, 2002
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)
Biogenex Laboratories
Pathology
161d
Cleared
Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
Dako Corp.
Pathology
102d
Cleared
Aug 12, 1999
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
Ventana, Inc.
Pathology
232d