Atlas FDA

MYA

12 FDA 510(k) clearances · Product code

344 daysmedian time to decision
635 days90th percentile
12clearances measured

FDA profile

Official device name
Immunohistochemistry Antibody Assay, Estrogen 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
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra (K183100)Leica Biosystems Newcastle, Limited2018-12-07
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (K170028)Dako Denmark A/S2017-12-21
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K122556)Leica Biosystems Newcastle, Ltd.2014-05-19
MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI (K120663)Dako North America, Inc.2013-02-12
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY (K110215)Ventana Medical Systems, Inc.2012-12-17
MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 (K081286)Dako North America, Inc.2009-05-08
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) (K061360)Lab Vision Corp.2006-06-27
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (K060227)Vision Biosystems, Inc.2006-05-25
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K012138)Chroma Vision Medical Systems, Inc.2002-09-30
BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) (K013148)Biogenex Laboratories2002-02-28
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (K993957)Dako Corp.2000-03-03
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11) (K984567)Ventana, Inc.1999-08-12

Track MYA automatically

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