
Leeco Diagnostics, Inc.
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CONCEP-7-BHCG (EIA) is an FDA 510(k)-cleared medical device (K844153) manufactured by Leeco Diagnostics, 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 December 13, 1984. Regulation: 8.