
Bd Becton Dickinson Vacutainer Systems Preanalytic
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PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE is an FDA 510(k)-cleared medical device (K844171) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 1984. Regulation: 8.