MYA · Class II · 21 CFR 864.1860

FDA Product Code MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor

Leading manufacturers include Ventana Medical Systems, Inc., Leica Biosystems Newcastle, Limited and Dako Corp..

12
Total
12
Cleared
295d
Avg days
1999
Since

FDA 510(k) Cleared Immunohistochemistry Antibody Assay, Estrogen Receptor Devices (Product Code MYA)

12 devices
1–12 of 12
Cleared Dec 07, 2018
Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
K183100
Leica Biosystems Newcastle, Limited
Pathology · 30d
Cleared Dec 17, 2012
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215
Ventana Medical Systems, Inc.
Pathology · 719d
Cleared Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957
Dako Corp.
Pathology · 102d

About Product Code MYA - Regulatory Context