Dako Monoclonal Mouse Anti-Human Estrogen Receptor
FDA 510(k) K993957 · Dako Corp.
510(k) numberK993957
Submission
- Device name
- Dako Monoclonal Mouse Anti-Human Estrogen Receptor
- Applicant
- Dako Corp.
Carpinteria, CA, US - Received
- November 22, 1999
- Decision date
- March 3, 2000
- 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 |
| 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 |
| 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 |
More from Biogenex Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…MXZ · Traditional | 02/28/2002SE |
| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | 06/21/1999SE |
| K991402 | Dako Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell…GKZ · Traditional | 06/21/1999SE |
| K980635 | Dako Mouse Anti-Human B-Cell, CD19/RPE-CY5, Clone HD37GKZ · Traditional | 07/22/1998SE |
| K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…DEH · Traditional | 12/12/1997SE |
| K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, BER-H2 Antibody for Immunoenzymatic…DEH · Traditional | 11/06/1997SE |
| K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/RpeGKZ · Traditional | 06/24/1997SE |
| K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) RpeGKZ · Traditional | 07/16/1996SE |
| K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDEH · Traditional | 07/05/1996SE |
| K961435 | Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/RpeGKZ · Traditional | 06/14/1996SE |
Questions and answers
When was Dako Monoclonal Mouse Anti-Human Estrogen Receptor cleared by the FDA?
Dako Monoclonal Mouse Anti-Human Estrogen Receptor (K993957) received a 510(k) decision of Substantially Equivalent on March 3, 2000, 102 days after the submission was received.
What is the product code of K993957?
The FDA product code is MYA – Immunohistochemistry Antibody Assay, Estrogen Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.