Panels › Hematology › Product code MYA · Class 2
Immunohistochemistry Antibody Assay, Estrogen Receptor
Regulation 864.1860
0510(k)s in 12 months (12 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MYA
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems, Inc. | 1 | 3 |
| Dako North America, Inc. | 2 | 0 |
| Leica Biosystems Newcastle, Limited | 2 | 0 |
| Biogenex Laboratories | 1 | 0 |
| Chroma Vision Medical Systems, Inc. | 1 | 0 |
| Dako Corp. | 1 | 0 |
| Dako Denmark A/S | 1 | 0 |
| Lab Vision Corp. | 1 | 0 |
| Ventana, Inc. | 1 | 0 |
| Vision Biosystems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2018 | K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Pri Leica Biosystems Newcastle, Limited, GB | MYA |
| Dec 21, 2017 | K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) Dako Denmark A/S, DK | MYA |
| May 19, 2014 | K122556 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) Leica Biosystems Newcastle, Ltd. | MYA |
| Feb 12, 2013 | K120663 | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI Dako North America, Inc. | MYA |
| Dec 17, 2012 | K110215 | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Systems, Inc. | MYA |
| May 8, 2009 | K081286 | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 Dako North America, Inc. | MYA |
| Jun 27, 2006 | K061360 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) Lab Vision Corp. | MYA |
| May 25, 2006 | K060227 | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) Vision Biosystems, Inc. | MYA |
| Sep 30, 2002 | K012138 | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) Chroma Vision Medical Systems, Inc. | MYA |
| Feb 28, 2002 | K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) Biogenex Laboratories | MYA |
| Mar 3, 2000 | K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR Dako Corp. | MYA |
| Aug 12, 1999 | K984567 | VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) Ventana, Inc. | MYA |
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