Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)
FDA 510(k) K061360 · Lab Vision Corp.
510(k) numberK061360
Submission
- Device name
- Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1)
- Applicant
- Lab Vision Corp.
Fremont, CA, US - Received
- May 16, 2006
- Decision date
- June 27, 2006
- 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
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|---|---|---|---|
| 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 |
| K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone EpiMYA · Traditional | Dako North America, Inc. | 02/12/2013SE |
| 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 |
| 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 |
|---|---|---|
| K060462 | Neomarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)MXZ · Traditional | 04/24/2006SE |
Questions and answers
When was Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1) cleared by the FDA?
Neomarkers Rabbit Monoclonal Anti-Human Estrogen Rece[Ptor Antibody (Clone SP1) (K061360) received a 510(k) decision of Substantially Equivalent on June 27, 2006, 42 days after the submission was received.
What is the product code of K061360?
The FDA product code is MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.