ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO is an FDA 510(k)-cleared medical device (K991079) manufactured by Princeton BioMeditech Corp.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1999. Regulation: 8.