
Euro-Diagnostics BV
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TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE is an FDA 510(k)-cleared medical device (K851148) manufactured by Euro-Diagnostics BV. 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 28, 1985. Regulation: 8.