510(k) K183100

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra by Leica Biosystems Newcastle, Limited — Product Code MYA

K183100 is an FDA 510(k) premarket notification submitted by Leica Biosystems Newcastle, Limited for the device "Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra". The FDA issued a decision of Substantially Equivalent on December 7, 2018. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Leica Biosystems Newcastle, Limited has at least 2 other 510(k) clearances on record.