
Em Diagnostic Systems, Inc.
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ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 is an FDA 510(k)-cleared medical device (K913706) 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 September 26, 1991. Regulation: 8.