
Bioclinical Group
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BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K823004) manufactured by Bioclinical Group. 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 November 4, 1982. Regulation: 8.