
Teco Diagnostics
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THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST is an FDA 510(k)-cleared medical device (K961629) manufactured by Teco Diagnostics. 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 10, 1996. Regulation: 8.