
Em Diagnostic Systems, Inc.
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SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 is an FDA 510(k)-cleared medical device (K895119) manufactured by Em Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 1989. Regulation: 8.