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

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 is an FDA 510(k)-cleared medical device (K141114) manufactured by Bio-Rad Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 2015. Regulation: 8.