CARDIO REP LD CONTROL - CAT NO. 3325

CARDIO REP LD CONTROL - CAT NO. 3325 is an FDA 510(k)-cleared medical device (K950801) manufactured by Helena Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 29, 1995. Regulation: 8.