RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY is an FDA 510(k)-cleared medical device (K001032) manufactured by Otsuka Pharmaceutical Co., Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 23, 2000. Regulation: 8.