Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining
FDA 510(k) K020023 · Dako Corp.
510(k) numberK020023
Submission
- Device name
- Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining
- Applicant
- Dako Corp.
Carpinteria, CA, US - Received
- January 3, 2002
- Decision date
- February 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXZ – Immunohistochemistry Assay, Antibody, Progesterone Receptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Specialty
- Hematology
Other 510(k)s with product code MXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse…MXZ · Traditional | Leica Biosystems Newcastle, Ltd. | 03/06/2020SE |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra…MXZ · Special | Leica Biosystems Newcastle, Limited | 12/07/2018SE |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use…MXZ · Traditional | Dako Denmark A/S | 12/21/2017SE |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid…MXZ · Special | Leica Biosystems Newcastle, Limited | 07/21/2017SE |
| K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)…MXZ · Special | Dako North America, Inc. | 05/03/2016SE |
| K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-To-Use (Link)MXZ · Traditional | Dako North America, Inc. | 12/09/2013SE |
| K103818 | Confirm Anti-Progestorone Receptor (1E2) Rabbit Monoclonal Primary AntibodyMXZ · Traditional | Ventana Medical Sytems, Inc. | 11/16/2011SE |
| K062615 | Vision Biosystems Progesterone Receptor PGR Clone 16MXZ · Abbreviated | Vision Biosystems, Inc. | 01/29/2007SE |
| K060462 | Neomarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)MXZ · Traditional | Lab Vision Corp. | 04/24/2006SE |
| K042884 | Dakocytomation Er/Pr Pharmdx KitMXZ · Traditional | Dakocytomation California, Inc. | 02/15/2005SE |
More from Dakocytomation California, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorMYA · Traditional | 03/03/2000SE |
| 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 Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining cleared by the FDA?
Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining (K020023) received a 510(k) decision of Substantially Equivalent on February 28, 2002, 56 days after the submission was received.
What is the product code of K020023?
The FDA product code is MXZ – Immunohistochemistry Assay, Antibody, Progesterone Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.