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Hemagen Diagnostics, Inc.
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RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 is an FDA 510(k)-cleared medical device (K031101) manufactured by Hemagen Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 15, 2003. Regulation: 8.