FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
FDA 510(k) K160922 · Dako North America, Inc.
510(k) numberK160922
Submission
- Device name
- FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
- Applicant
- Dako North America, Inc.
Carpinteria, CA, US - Received
- April 4, 2016
- Decision date
- May 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K012960 | Biogenex Monoclonal Anti-Progesterone ReceptorMXZ · Traditional | Biogenex Laboratories | 03/08/2002SE |
More from Biogenex Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K130861 | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Ready-To-Use (Link)MXZ · Traditional | 12/09/2013SE |
| K120663 | Monoclonal Rabbit Anti-Human Estrogen Receptor (Er) a, Clone EpiMYA · Traditional | 02/12/2013SE |
| K081286 | Monoclonal Rabbit Anti Human Estrogen Receptor Alpha Antibody Clone SP1, Model M3634MYA · Traditional | 05/08/2009SE |
Questions and answers
When was FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) cleared by the FDA?
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (K160922) received a 510(k) decision of Substantially Equivalent on May 3, 2016, 29 days after the submission was received.
What is the product code of K160922?
The FDA product code is MXZ – Immunohistochemistry Assay, Antibody, Progesterone Receptor, a Class II (moderate risk) device regulated under 21 CFR 864.1860.