MYA — Immunohistochemistry Antibody Assay, Estrogen Receptor Class II
FDA product code MYA covers "Immunohistochemistry Antibody Assay, Estrogen Receptor", a Class II medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |