UBI MAGIWEL(TM) TSH QUANTITATIVE

UBI MAGIWEL(TM) TSH QUANTITATIVE is an FDA 510(k)-cleared medical device (K864079) manufactured by United Biotech, 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 December 15, 1986. Regulation: 8.