510(k) K082953

ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 by Biokit, S.A. — Product Code KXT

K082953 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01". The FDA issued a decision of Substantially Equivalent on December 22, 2008. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Biokit, S.A. has at least 10 other 510(k) clearances on record.