MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor Class II
FDA product code MXZ covers "Immunohistochemistry Assay, Antibody, Progesterone Receptor", a Class II medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel. At least 13 recent 510(k) clearances have been granted under this product code.
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 |