
Em Diagnostic Systems, Inc.
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EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 is an FDA 510(k)-cleared medical device (K862453) 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 August 18, 1986. Regulation: 8.