BION CMV-G TEST SYSTEM

BION CMV-G TEST SYSTEM is an FDA 510(k)-cleared medical device (K880679) manufactured by Bion Ent., Ltd.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 1988. Regulation: 8.