
Canyon Diagnostics, Inc.
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CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 is an FDA 510(k)-cleared medical device (K964640) manufactured by Canyon Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 12, 1996. Regulation: 8.