
Dade Behring, Inc.
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AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A is an FDA 510(k)-cleared medical device (K053157) manufactured by Dade Behring, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 8, 2005. Regulation: 8.