QBC E-Z PREP

QBC E-Z PREP is an FDA 510(k)-cleared medical device (K913399) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 October 17, 1991. Regulation: 8.