Product code MYA
- Device name
- Immunohistochemistry Antibody Assay, Estrogen Receptor
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.1860
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | Dako North America, Inc. | 2009-05-08 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810119676580 | ANTI-ESTROGEN RECEPTOR-ALPHA | BIOGENEX LABORATORIES | 2023-05-16 |
| 00810119677655 | ANTI-ESTROGEN RECEPTOR-ALPHA | BIOGENEX LABORATORIES | 2023-04-21 |
| 05055331334107 | BOND™ | LEICA BIOSYSTEMS NEWCASTLE LTD | 2022-12-16 |
| 05055331334497 | BOND™ | LEICA BIOSYSTEMS NEWCASTLE LTD | 2022-12-16 |
| 00847627002273 | Estrogen Receptor (ER) [6F11 + SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627002266 | Estrogen Receptor (ER) [6F11 + SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627002105 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627002051 | Estrogen Receptor (ER) [6F11] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627024602 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627002044 | Estrogen Receptor (ER) [1D5] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627002006 | Estrogen Receptor (ER) [6F11 + SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001993 | Estrogen Receptor (ER) [6F11 + SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001955 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001870 | Estrogen Receptor (ER) [6F11] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001863 | Estrogen Receptor (ER) [1D5] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001634 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001627 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001610 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001535 | Estrogen Receptor (ER) [6F11] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001528 | Estrogen Receptor (ER) [1D5] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001511 | Estrogen Receptor (ER) [1D5] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001412 | Estrogen Receptor (ER) [SP1] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001313 | Estrogen Receptor (ER) [6F11] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001306 | Estrogen Receptor (ER) [1D5] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 00847627001290 | Estrogen Receptor (ER) [1D5] | BIOCARE MEDICAL LLC | 2022-12-07 |
| 05700571105146 | Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294 | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 05700571104897 | Dako ER/PR pharmDx Kit (Link) | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 05700571104354 | Dako ER/PR pharmDx Kit For the Dako Autostainer | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 04015630972241 | CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2015-12-31 |
| 04015630972234 | CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2015-12-31 |