510(k) K993957

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR by Dako Corp. — Product Code MYA

K993957 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR". The FDA issued a decision of Substantially Equivalent on March 3, 2000. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Dako Corp. has at least 10 other 510(k) clearances on record.