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 |