ACCUWELL TSH, MODEL KAW-TSH-960

ACCUWELL TSH, MODEL KAW-TSH-960 is an FDA 510(k)-cleared medical device (K001455) manufactured by Neometrics, 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 November 1, 2000. Regulation: 8.