510(k) K183100
- Device
- Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody For Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
- Applicant
- Leica Biosystems Newcastle Limited
- 510(k) number
- K183100
- Product code
- MYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-07
- Date received
- 2018-11-07
- Regulation
- 864.1860
- Classification name
- Immunohistochemistry Antibody Assay, Estrogen Receptor
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jeremy Allen
- Address
- Balliol Business Park W. Benton Ln. Newcastle Upon Tyne GB NE12 8EW NE12 8EW
FDA Registration Numbers#
- 3004859032
- 1831638
- 2022180
- 3012214605
- 3008776165
- 3010939897
- 3004140393
- 3009189893
- 2916205
- 2028492
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary