Atlas FDA

MXZ

13 FDA 510(k) clearances · Product code

119 daysmedian time to decision
322 days90th percentile
13clearances measured

FDA profile

Official device name
Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device class
Class II (moderate risk)
Regulation
21 CFR 864.1860
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). (K193393)Leica Biosystems Newcastle, Ltd.2020-03-06
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody (K183102)Leica Biosystems Newcastle, Limited2018-12-07
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (K170005)Dako Denmark A/S2017-12-21
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (K171753)Leica Biosystems Newcastle, Limited2017-07-21
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) (K160922)Dako North America, Inc.2016-05-03
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) (K130861)Dako North America, Inc.2013-12-09
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY (K103818)Ventana Medical Sytems, Inc.2011-11-16
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 (K062615)Vision Biosystems, Inc.2007-01-29
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) (K060462)Lab Vision Corp.2006-04-24
DAKOCYTOMATION ER/PR PHARMDX KIT (K042884)Dakocytomation California, Inc.2005-02-15
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (K012960)Biogenex Laboratories2002-03-08
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING (K020023)Dako Corp.2002-02-28
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) (K990618)Ventana Medical Systems, Inc.1999-07-23

Track MXZ automatically

Every clearance here is in the API, with alerts when new ones post.