
Sigma Diagnostics, Inc.
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EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) is an FDA 510(k)-cleared medical device (K972041) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 21, 1997. Regulation: 8.