
Clinical Assays, Inc.
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GAMMADAB (125 1) FOLATE RADIOASSAY KIT is an FDA 510(k)-cleared medical device (K791079) manufactured by Clinical Assays, 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 July 16, 1979. Regulation: 8.