510(k) K941604

VENTANA ANTI-CD4 PRIMARY ANTIBODY by Ventana Medical Systems, Inc. — Product Code DEH

K941604 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "VENTANA ANTI-CD4 PRIMARY ANTIBODY". The FDA issued a decision of Substantially Equivalent on February 14, 1997. The device falls under product code DEH (Lambda, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.