BACTIDROP(TM) LACTOPHENOL ANILINE BLUE

BACTIDROP(TM) LACTOPHENOL ANILINE BLUE is an FDA 510(k)-cleared medical device (K913005) manufactured by Remel Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 1991. Regulation: 8.