510(k) K945125

DUPONT ACA VANCOMYCIN (VANC) METHOD by The DU Pont Co. — Product Code LEH

K945125 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "DUPONT ACA VANCOMYCIN (VANC) METHOD". The FDA issued a decision of Substantially Equivalent on March 10, 1995. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. The DU Pont Co. has at least 10 other 510(k) clearances on record.