
Heraeus Kulzer, Inc.
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TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 is an FDA 510(k)-cleared medical device (K925203) manufactured by Heraeus Kulzer, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 24, 1992. Regulation: 8.