ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14

ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 is an FDA 510(k)-cleared medical device (K912809) manufactured by Em 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 August 11, 1991. Regulation: 8.