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Biosafe Laboratories, Inc.
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SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) is an FDA 510(k)-cleared medical device (K011525) 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 July 15, 2001. Regulation: 8.