VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) is an FDA 510(k)-cleared medical device (K861449) manufactured by Exel Intl.. 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 September 15, 1986. Regulation: 8.