LD-1 CONTROL-LEVEL 1 & 2

LD-1 CONTROL-LEVEL 1 & 2 is an FDA 510(k)-cleared medical device (K930874) manufactured by Cala Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 21, 1993. Regulation: 8.