
Hybritech, Inc.
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TAMDEM-R THYROID STIMULATING HORMONE KIT is an FDA 510(k)-cleared medical device (K822705) manufactured by Hybritech, 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 October 12, 1982. Regulation: 8.