
Ventrex Laboratories, Inc.
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VENTREZYME T4U IMMUNOASSAY T4U is an FDA 510(k)-cleared medical device (K841024) manufactured by Ventrex Laboratories, 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 May 8, 1984. Regulation: 8.