
Baxter Diagnostics, Inc.
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DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 is an FDA 510(k)-cleared medical device (K933437) manufactured by Baxter Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 27, 1993. Regulation: 8.