510(k) K072036

ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 by Biokit, S.A. — Product Code LEH

K072036 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01". The FDA issued a decision of Substantially Equivalent on March 19, 2008. The device falls under product code LEH (Radioimmunoassay, Vancomycin), a Class II device regulated under 21 CFR 862.3950. Biokit, S.A. has at least 10 other 510(k) clearances on record.