
Medical Analysis Systems, Inc.
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CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK is an FDA 510(k)-cleared medical device (K010111) 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 February 27, 2001. Regulation: 8.