510(k) K062615

VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 by Vision Biosystems, Inc. — Product Code MXZ

K062615 is an FDA 510(k) premarket notification submitted by Vision Biosystems, Inc. for the device "VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16". The FDA issued a decision of Substantially Equivalent on January 29, 2007. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Vision Biosystems, Inc. has at least 1 other 510(k) clearance on record.