MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor Class II
FDA Device Classification
Classification Details
- Product Code
- MYA
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K183100 | leica biosystems newcastle, limited | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Re | December 7, 2018 |
| K170028 | dako denmark | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmi | December 21, 2017 |
| K122556 | leica biosystems newcastle | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | May 19, 2014 |
| K120663 | dako north america | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | February 12, 2013 |
| K110215 | ventana medical systems | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | December 17, 2012 |
| K081286 | dako north america | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M | May 8, 2009 |
| K061360 | lab vision | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) | June 27, 2006 |
| K060227 | vision biosystems | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | May 25, 2006 |
| K012138 | chroma vision medical systems | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | September 30, 2002 |
| K013148 | biogenex laboratories | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | February 28, 2002 |
| K993957 | dako | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | March 3, 2000 |
| K984567 | ventana | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) | August 12, 1999 |