510(k) K081286

Device: MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
Applicant: DAKO NORTH AMERICA, INC.
510(k) number: K081286
Product code: MYA
Decision: Substantially Equivalent (SESE)
Decision date: 2009-05-08
Date received: 2008-05-07
Regulation: 864.1860
Classification name: Immunohistochemistry Antibody Assay, Estrogen Receptor
Medical specialty: Hematology
Review panel: Pathology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K183100	Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra	Leica Biosystems Newcastle, Limited	2018-12-07
K170028	FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)	Dako Denmark A/S	2017-12-21
K122556	VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)	Leica Biosystems Newcastle, Ltd.	2014-05-19
K120663	MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI	Dako North America, Inc.	2013-02-12
K110215	CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY	Ventana Medical Systems, Inc.	2012-12-17
K061360	NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)	Lab Vision Corp.	2006-06-27
K060227	VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)	Vision Biosystems, Inc.	2006-05-25
K012138	MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)	Chroma Vision Medical Systems, Inc.	2002-09-30
K013148	BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)	Biogenex Laboratories	2002-02-28
K993957	DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR	Dako Corp.	2000-03-03
K984567	VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)	Ventana, Inc.	1999-08-12

summary

Decision Summary