
Ventrex Laboratories, Inc.
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VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC is an FDA 510(k)-cleared medical device (K843230) 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 September 3, 1984. Regulation: 8.