
Lecco Diagnostics, Inc.
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LEE-BEAD TSH(EIA) is an FDA 510(k)-cleared medical device (K852224) manufactured by Lecco 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 July 8, 1985. Regulation: 8.