ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I

ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I is an FDA 510(k)-cleared medical device (K911169) manufactured by Analytical Control Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 30, 1991. Regulation: 8.