
Clinical Data
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ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) is an FDA 510(k)-cleared medical device (K030528) manufactured by Clinical Data. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 16, 2003. Regulation: 8.