
Boehringer Mannheim Corp.
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ENZYMUN TEST(R) TSH-S is an FDA 510(k)-cleared medical device (K900277) manufactured by Boehringer Mannheim 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 April 10, 1990. Regulation: 8.