Panels › Hematology › Product code MXZ · Class 2
Immunohistochemistry Assay, Antibody, Progesterone Receptor
Regulation 864.1860
0510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in MXZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Leica Biosystems Newcastle, Limited | 3 | 0 |
| Dako North America, Inc. | 2 | 0 |
| Ventana Medical Systems, Inc. | 1 | 1 |
| Zymed Laboratories Inc. | 0 | 2 |
| Biogenex Laboratories | 1 | 0 |
| Dako Corp. | 1 | 0 |
| Dako Denmark A/S | 1 | 0 |
| Dakocytomation California, Inc. | 1 | 0 |
| Lab Vision Corp. | 1 | 0 |
| Ventana Medical Sytems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2020 | K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Leica Biosystems Newcastle, Ltd., GB | MXZ |
| Dec 7, 2018 | K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal An Leica Biosystems Newcastle, Limited, GB | MXZ |
| Dec 21, 2017 | K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) Dako Denmark A/S, DK | MXZ |
| Jul 21, 2017 | K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progest Leica Biosystems Newcastle, Limited, GB | MXZ |
| May 3, 2016 | K160922 | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Dako North America, Inc. | MXZ |
| Dec 9, 2013 | K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) Dako North America, Inc. | MXZ |
| Nov 16, 2011 | K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY Ventana Medical Sytems, Inc. | MXZ |
| Jan 29, 2007 | K062615 | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 Vision Biosystems, Inc. | MXZ |
| Apr 24, 2006 | K060462 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) Lab Vision Corp. | MXZ |
| Feb 15, 2005 | K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT Dakocytomation California, Inc. | MXZ |
| Mar 8, 2002 | K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR Biogenex Laboratories | MXZ |
| Feb 28, 2002 | K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING Dako Corp. | MXZ |
| Jul 23, 1999 | K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) Ventana Medical Systems, Inc. | MXZ |
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