MYA · Class II · 21 CFR 864.1860

FDA Product Code MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor

Leading manufacturers include Leica Biosystems Newcastle, Limited.

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

About Product Code MYA - Regulatory Context