ALIBI BIOLOGICAL INDICATOR, MODEL WS

ALIBI BIOLOGICAL INDICATOR, MODEL WS is an FDA 510(k)-cleared medical device (K024079) manufactured by Arden Laboratories, Incorporated. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2003. Regulation: 8.