Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone Epi
FDA 510(k) K120663 · Dako North America, Inc.
510(k) numberK120663
Submission
- Device name
- Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone Epi
- Applicant
- Dako North America, Inc.
Carpinteria, CA, US - Received
- March 5, 2012
- Decision date
- February 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Other 510(k)s with product code MYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor…MYA · Special | Leica Biosystems Newcastle, Limited | 12/07/2018SE |
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)MYA · Traditional | Dako Denmark A/S | 12/21/2017SE |
| K122556 | Vision Biosystems Estrogen Receptor Clone 6F11 (Er 6F11)MYA · Traditional | Leica Biosystems Newcastle, Ltd. | 05/19/2014SE |
| K110215 | Confirm Anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary AntibodyMYA · Traditional | Ventana Medical Systems, Inc. | 12/17/2012SE |
| K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634MYA · Traditional | Dako North America, Inc. | 05/08/2009SE |
| K061360 | Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)MYA · Traditional | Lab Vision Corp. | 06/27/2006SE |
| K060227 | Vision Biosystems Estrogen Receptor Clone 6F11 (Er 6F11)MYA · Abbreviated | Vision Biosystems, Inc. | 05/25/2006SE |
| K012138 | Modification to Acis (Automated Cellular Imaging System)MYA · Traditional | Chroma Vision Medical Systems, Inc. | 09/30/2002SE |
| K013148 | Biogenex Monoclonal Anti-Estrogen Receptor(Clone ER88)MYA · Traditional | Biogenex Laboratories | 02/28/2002SE |
| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorMYA · Traditional | Dako Corp. | 03/03/2000SE |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)…MXZ · Special | 05/03/2016SE |
| K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-To-Use (Link)MXZ · Traditional | 12/09/2013SE |
| K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634MYA · Traditional | 05/08/2009SE |
Questions and answers
When was Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone Epi cleared by the FDA?
Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone Epi (K120663) received a 510(k) decision of Substantially Equivalent on February 12, 2013, 344 days after the submission was received.
What is the product code of K120663?
The FDA product code is MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.