
Serono Diagnostics, Inc.
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T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS is an FDA 510(k)-cleared medical device (K883085) manufactured by Serono Diagnostics, 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 September 8, 1988. Regulation: 8.