MODIFICATION TO DOCUMENT THYROID CAL.VER

MODIFICATION TO DOCUMENT THYROID CAL.VER is an FDA 510(k)-cleared medical device (K993014) manufactured by Casco-Nerl Diagnostics Corporation (Maine). This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 25, 1999. Regulation: 8.