ABBOTT AXSYM 3RD GENERATION TSH ASSAY

ABBOTT AXSYM 3RD GENERATION TSH ASSAY is an FDA 510(k)-cleared medical device (K981060) manufactured by Abbott Laboratories. 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 28, 1998. Regulation: 8.