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Alfa Wassermann, Inc.
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S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) is an FDA 510(k)-cleared medical device (K091413) manufactured by Alfa Wassermann, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 25, 2009. Regulation: 8.