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Diazyme Laboratories
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SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER is an FDA 510(k)-cleared medical device (K092911) manufactured by Diazyme Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 25, 2010. Regulation: 8.