
ACON Laboratories, Inc.
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ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) is an FDA 510(k)-cleared medical device (K042272) manufactured by ACON Laboratories, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 2005. Regulation: 8.