510(k) K990618

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) by Ventana Medical Systems, Inc. — Product Code MXZ

K990618 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)". The FDA issued a decision of Substantially Equivalent on July 23, 1999. The device falls under product code MXZ (Immunohistochemistry Assay, Antibody, Progesterone Receptor), a Class II device regulated under 21 CFR 864.1860. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.