
Roche Diagnostic Systems, Inc.
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ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT is an FDA 510(k)-cleared medical device (K971902) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 15, 1997. Regulation: 8.