MERIFLUOR(TM) PNEUMOCYSTIS

MERIFLUOR(TM) PNEUMOCYSTIS is an FDA 510(k)-cleared medical device (K881608) 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 August 3, 1988. Regulation: 8.