LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2

LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 is an FDA 510(k)-cleared medical device (K932660) manufactured by More Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 27, 1993. Regulation: 8.