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Medical Analysis Systems, Inc.
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ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H is an FDA 510(k)-cleared medical device (K041194) manufactured by Medical Analysis 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 15, 2004. Regulation: 8.