MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION is an FDA 510(k)-cleared medical device (K904400) manufactured by Meridian Diagnostics, 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 October 15, 1990. Regulation: 8.