
Miles, Inc.
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IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM is an FDA 510(k)-cleared medical device (K935287) manufactured by Miles, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 2, 1994. Regulation: 8.