MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor Class II
FDA Device Classification
Classification Details
- Product Code
- MXZ
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K193393 | leica biosystems newcastle | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid | March 6, 2020 |
| K183102 | leica biosystems newcastle, limited | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra | December 7, 2018 |
| K170005 | dako denmark | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to | December 21, 2017 |
| K171753 | leica biosystems newcastle, limited | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra | July 21, 2017 |
| K160922 | dako north america | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use | May 3, 2016 |
| K130861 | dako north america | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE ( | December 9, 2013 |
| K103818 | ventana medical sytems | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | November 16, 2011 |
| K062615 | vision biosystems | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | January 29, 2007 |
| K060462 | lab vision | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP | April 24, 2006 |
| K042884 | dakocytomation california | DAKOCYTOMATION ER/PR PHARMDX KIT | February 15, 2005 |
| K012960 | biogenex laboratories | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | March 8, 2002 |
| K020023 | dako | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY | February 28, 2002 |
| K990618 | ventana medical systems | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | July 23, 1999 |