NEGATIVE CONTROL SERUM FOR CF RO ID

NEGATIVE CONTROL SERUM FOR CF RO ID is an FDA 510(k)-cleared medical device (K791385) manufactured by Immuno-Mycologics, Inc.. 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 15, 1979. Regulation: 8.