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Diagnostica Stago, Inc.
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STA-HYBRID HEP CALIBRATOR is an FDA 510(k)-cleared medical device (K092937) manufactured by Diagnostica Stago, 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 August 1, 2010. Regulation: 8.