
Tosoh Bioscience, Inc.
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ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET is an FDA 510(k)-cleared medical device (K121533) manufactured by Tosoh Bioscience, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2012. Regulation: 8.