CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)

CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) is an FDA 510(k)-cleared medical device (K913133) manufactured by Bionostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 26, 1991. Regulation: 8.