510(k) K060462

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) by Lab Vision Corp. — Product Code MXZ

K060462 is an FDA 510(k) premarket notification submitted by Lab Vision Corp. for the device "NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)". The FDA issued a decision of Substantially Equivalent on April 24, 2006. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Lab Vision Corp. has at least 1 other 510(k) clearance on record.