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Biosafe Laboratories, Inc.
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BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) is an FDA 510(k)-cleared medical device (K003752) manufactured by Biosafe Laboratories, 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 March 22, 2001. Regulation: 8.