
Medcom Diagnostics, Inc.
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THYRODOT-4 ANTISERA LYOPHOLIZED is an FDA 510(k)-cleared medical device (K772064) manufactured by Medcom 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 November 13, 1977. Regulation: 8.