
Akonni Biosystems, Inc.
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TruDiagnosis System is an FDA 510(k)-cleared medical device (K183530) manufactured by Akonni Biosystems, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2019. Regulation: 8.