JUSTONE(TM)

JUSTONE(TM) is an FDA 510(k)-cleared medical device (K912846) manufactured by Sensititre Microbiology A Div. of Radiometer. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 1991. Regulation: 8.