FDA 510(k) Applications for Medical Device Product Code "MXZ"
(Immunohistochemistry Assay,Antibody,Progesterone Receptor)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K012960 | BIOGENEX LABORATORIES | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | 03/08/2002 |
| K020023 | DAKO CORP. | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | 02/28/2002 |
| K170005 | DAKO DENMARK A/S | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | 12/21/2017 |
| K160922 | Dako North America, Inc. | 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) | 05/03/2016 |
| K130861 | DAKO NORTH AMERICA, INC. | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | 12/09/2013 |
| K042884 | DAKOCYTOMATION CALIFORNIA, INC. | DAKOCYTOMATION ER/PR PHARMDX KIT | 02/15/2005 |
| K060462 | LAB VISION CORP. | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) | 04/24/2006 |
| K183102 | Leica Biosystems Newcastle Limited | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | 12/07/2018 |
| K171753 | Leica Biosystems Newcastle Limited | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | 07/21/2017 |
| K193393 | Leica Biosystems Newcastle Ltd. | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | 03/06/2020 |
| K990618 | VENTANA MEDICAL SYSTEMS, INC. | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | 07/23/1999 |
| K103818 | VENTANA MEDICAL SYTEMS, INC | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | 11/16/2011 |
| K062615 | VISION BIOSYSTEMS INC. | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | 01/29/2007 |
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