OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT

OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT is an FDA 510(k)-cleared medical device (K952466) manufactured by Olympus America, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 4, 1995. Regulation: 8.