Product code MXZ— Hematology

FDA has cleared 13 devices under product code MXZ between 1999 and 2020, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20201 clearance
• 20181 clearance
• 20172 clearances
• 20161 clearance
• 20131 clearance
• 20111 clearance
• 20071 clearance
• 20061 clearance
• 20051 clearance
• 20022 clearances
• 19991 clearance

• Leica Biosystems Newcastle, Limited2 clearances
• Dako North America, Inc.2 clearances
• Vision Biosystems, Inc.1 clearance
• Ventana Medical Sytems, Inc.1 clearance
• Ventana Medical Systems, Inc.1 clearance
• Leica Biosystems Newcastle, Ltd.1 clearance
• Lab Vision Corp.1 clearance
• Dakocytomation California, Inc.1 clearance
• Dako Denmark A/S1 clearance
• Dako Corp.1 clearance

• 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 AntibodyLeica 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 16Leica Biosystems Newcastle, Limited·2017-07-21
• K160922 — FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link) +1 moreDako 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 ANTIBODYVentana Medical Sytems, Inc.·2011-11-16
• K062615 — VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16Vision 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 KITDakocytomation California, Inc.·2005-02-15
• K012960 — BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORBiogenex Laboratories·2002-03-08
• K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGDako Corp.·2002-02-28
• K990618 — VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)Ventana Medical Systems, Inc.·1999-07-23