RUBELISA (RUBESTAT)

RUBELISA (RUBESTAT) is an FDA 510(k)-cleared medical device (K950227) manufactured by Bio-Whittaker, Inc., A Cambrex Co.. 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 14, 1995. Regulation: 8.