510(k) K193393
- Device
- BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
- Applicant
- Leica Biosystems Newcastle Ltd.
- 510(k) number
- K193393
- Product code
- MXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-06
- Date received
- 2019-12-06
- Regulation
- 864.1860
- Classification name
- Immunohistochemistry Assay, Antibody, Progesterone Receptor
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Matthew West
- Address
- Balliol Business Park W. Benton Ln. Newcastle Upon Tyne GB NE12 8EW NE12 8EW
FDA Registration Numbers#
- 9610099
- 3013059683
- 3003423869
- 3012214605
- 3010939897
- 1831638
- 3004140393
- 3008776165
- 3004859032
- 3009189893
- 2028492
- 2022180
- 2916205
Source Documents#
Other 510(k) Records For Product Code MXZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary