MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE

MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE is an FDA 510(k)-cleared medical device (K944083) manufactured by Sherwood Medical Co.. 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 May 25, 1995. Regulation: 8.