THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II

THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II is an FDA 510(k)-cleared medical device (K911170) 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.