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Baxter Healthcare Corp
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CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 is an FDA 510(k)-cleared medical device (K901475) manufactured by Baxter Healthcare Corp. 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 19, 1990. Regulation: 8.