510(k) K951059

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY by Ciba Corning Diagnostics Corp. — Product Code LEH

K951059 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on June 19, 1995. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.