ORTHO* UNASSAYED CONTROL SERUM LEVEL III

ORTHO* UNASSAYED CONTROL SERUM LEVEL III is an FDA 510(k)-cleared medical device (K813322) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 16, 1981. Regulation: 8.