Product code MXZ
- Device name
- Immunohistochemistry Assay, Antibody, Progesterone Receptor
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.1860
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | Leica Biosystems Newcastle, Ltd. | 2020-03-06 |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | Leica Biosystems Newcastle, Limited | 2018-12-07 |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | Dako Denmark A/S | 2017-12-21 |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | Leica Biosystems Newcastle, Limited | 2017-07-21 |
| K160922 | 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) | Dako North America, Inc. | 2016-05-03 |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | Dako North America, Inc. | 2013-12-09 |
| K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Sytems, Inc. | 2011-11-16 |
| K062615 | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | Vision Biosystems, Inc. | 2007-01-29 |
| K060462 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) | Lab Vision Corp. | 2006-04-24 |
| K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | Dakocytomation California, Inc. | 2005-02-15 |
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | Biogenex Laboratories | 2002-03-08 |
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | 2002-02-28 |
| K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | Ventana Medical Systems, Inc. | 1999-07-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00847627037824 | Progesterone Receptor (PR) [16] | BIOCARE MEDICAL LLC | 2025-03-20 |
| 00810119676627 | ANTI-HUMAN PROGESTERONE RECEPTOR | BIOGENEX LABORATORIES | 2023-05-16 |
| 05055331334855 | BOND™ | LEICA BIOSYSTEMS NEWCASTLE LTD | 2022-12-16 |
| 05055331335104 | BOND™ | LEICA BIOSYSTEMS NEWCASTLE LTD | 2022-12-16 |
| 00847627002020 | Progesterone Receptor (PR) [PgR636] | BIOCARE MEDICAL LLC | 2022-12-13 |
| 00847627002037 | Progesterone Receptor (PR) [PgR636] | BIOCARE MEDICAL LLC | 2022-12-13 |
| 00847627031693 | Progesterone Receptor [PgR636] | BIOCARE MEDICAL LLC | 2022-12-13 |
| 00847627001986 | Progesterone Receptor (PR) [SP2] | BIOCARE MEDICAL LLC | 2022-12-13 |
| 05055331320339 | BOND | LEICA BIOSYSTEMS NEWCASTLE LTD | 2020-04-07 |
| 05700571108154 | FLEX Mono Mo A-Hu Progesterone Receptor Cl PgR 1294 RTU (Dako Omnis) | AGILENT TECHNOLOGIES, INC. | 2018-03-01 |
| 05700571101759 | FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link) | AGILENT TECHNOLOGIES, INC. | 2017-01-03 |
| 00850646007129 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-10-14 |
| 00850646007136 | Anti-PR | BIOGENEX LABORATORIES | 2016-10-14 |
| 05055331303158 | Novocastra™ | LEICA BIOSYSTEMS NEWCASTLE LTD | 2016-09-24 |
| 05055331304292 | BOND™ | LEICA BIOSYSTEMS NEWCASTLE LTD | 2016-09-24 |
| 00850646007051 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-09-23 |
| 00850646007044 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-09-23 |
| 00850646007037 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-09-23 |
| 00850646007006 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-09-23 |
| 00850646007013 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-09-23 |
| 00850646007020 | Anti-PR (Insite) | BIOGENEX LABORATORIES | 2016-09-23 |
| 00673693180344 | Progesterone Receptor Culture Supernatant with azide | RICHARD-ALLAN SCIENTIFIC COMPANY | 2016-09-21 |
| 00673693180337 | Progesterone Receptor Ready to use IHC (UVLP) | RICHARD-ALLAN SCIENTIFIC COMPANY | 2016-09-21 |
| 05700571105146 | Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294 | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 05700571104897 | Dako ER/PR pharmDx Kit (Link) | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 05700571104354 | Dako ER/PR pharmDx Kit For the Dako Autostainer | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 05700571102305 | Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 05700571102299 | Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 | AGILENT TECHNOLOGIES, INC. | 2016-09-16 |
| 04015630972203 | CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2015-12-31 |
| 04015630972180 | CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2015-12-31 |