REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK is an FDA 510(k)-cleared medical device (K970830) manufactured by Remel, 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 April 1, 1997. Regulation: 8.