510(k) K060227

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) by Vision Biosystems, Inc. — Product Code MYA

K060227 is an FDA 510(k) premarket notification submitted by Vision Biosystems, Inc. for the device "VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)". The FDA issued a decision of Substantially Equivalent on May 25, 2006. The device falls under product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor), a Class II device regulated under 21 CFR 864.1860. Vision Biosystems, Inc. has at least 1 other 510(k) clearance on record.