SYSTE MATE TIBC HEM NO. 67225

SYSTE MATE TIBC HEM NO. 67225 is an FDA 510(k)-cleared medical device (K850128) 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 January 31, 1985. Regulation: 8.