MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS is an FDA 510(k)-cleared medical device (K013662) manufactured by Quantimetrix Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 7, 2002. Regulation: 8.