QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2

QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 is an FDA 510(k)-cleared medical device (K961293) manufactured by Consolidated Technologies, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 1, 1996. Regulation: 8.