510(k) K110619

ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS by Biokit, S.A. — Product Code MRG

K110619 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS". The FDA issued a decision of Substantially Equivalent on November 23, 2011. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Biokit, S.A. has at least 10 other 510(k) clearances on record.