BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT

BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT is an FDA 510(k)-cleared medical device (K933939) manufactured by Organon Teknika Corp.. 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 February 6, 1994. Regulation: 8.