SCEPTOR GRAM POSITIVE MIC PANEL

SCEPTOR GRAM POSITIVE MIC PANEL is an FDA 510(k)-cleared medical device (K854101) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 1985. Regulation: 8.