SEROZYME FREE T3 IMMUNOASSAY

SEROZYME FREE T3 IMMUNOASSAY is an FDA 510(k)-cleared medical device (K902748) manufactured by Advanced Magnetics, 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 August 8, 1990. Regulation: 8.