REP 3 QUTO-FLUR CHOLESTEROL-30

REP 3 QUTO-FLUR CHOLESTEROL-30 is an FDA 510(k)-cleared medical device (K962914) 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 January 12, 1997. Regulation: 8.