BIOSTRIDE FREE T4 EIA TEST KIT

BIOSTRIDE FREE T4 EIA TEST KIT is an FDA 510(k)-cleared medical device (K981243) manufactured by Biostride 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 June 28, 1998. Regulation: 8.