NOVAPATH TSH ENZYME IMMUNOASSAY

NOVAPATH TSH ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K903311) manufactured by Bio-Rad. 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 September 6, 1990. Regulation: 8.