
Em Diagnostic Systems, Inc.
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EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 is an FDA 510(k)-cleared medical device (K862845) manufactured by Em Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 28, 1986. Regulation: 8.