ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS is an FDA 510(k)-cleared medical device (K991733) manufactured by Schiapparelli Biosystems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 12, 1999. Regulation: 8.