
Tosoh Bioscience, Inc.
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ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set is an FDA 510(k)-cleared medical device (K143075) manufactured by Tosoh Bioscience, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 1, 2015. Regulation: 8.