510(k) K141114

BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D by Bio-Rad Laboratories — Product Code MRG

K141114 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D". The FDA issued a decision of Substantially Equivalent on January 9, 2015. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.