RADIAS 3RD GENERATION TSH IMMUNOASSAY

RADIAS 3RD GENERATION TSH IMMUNOASSAY is an FDA 510(k)-cleared medical device (K935119) 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 April 5, 1994. Regulation: 8.