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International Enzymes, Inc.
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HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 is an FDA 510(k)-cleared medical device (K011169) manufactured by International Enzymes, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 17, 2001. Regulation: 8.