510(k) K013148

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) by Biogenex Laboratories — Product Code MYA

K013148 is an FDA 510(k) premarket notification submitted by Biogenex Laboratories for the device "BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)". The FDA issued a decision of Substantially Equivalent on February 28, 2002. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Biogenex Laboratories has at least 10 other 510(k) clearances on record.