FDA 510(k) Applications for Medical Device Product Code "MYA"
(Immunohistochemistry Antibody Assay, Estrogen Receptor)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013148 | BIOGENEX LABORATORIES | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | 02/28/2002 |
| K012138 | CHROMAVISION MEDICAL SYSTEMS, INC. | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | 09/30/2002 |
| K993957 | DAKO CORP. | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | 03/03/2000 |
| K170028 | DAKO DENMARK A/S | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | 12/21/2017 |
| K081286 | DAKO NORTH AMERICA, INC. | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | 05/08/2009 |
| K120663 | DAKO NORTH AMERICA, INC. | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | 02/12/2013 |
| K061360 | LAB VISION CORP. | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) | 06/27/2006 |
| K183100 | Leica Biosystems Newcastle Limited | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | 12/07/2018 |
| K122556 | LEICA BIOSYSTEMS NEWCASTLE LTD | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | 05/19/2014 |
| K110215 | VENTANA MEDICAL SYSTEMS, INC. | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | 12/17/2012 |
| K984567 | VENTANA, INC. | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) | 08/12/1999 |
| K060227 | VISION BIOSYSTEMS INC. | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | 05/25/2006 |
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