IQ TSH IMMUNOASSAY

IQ TSH IMMUNOASSAY is an FDA 510(k)-cleared medical device (K870244) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. 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 March 31, 1987. Regulation: 8.