
Nanoentek USA, Inc.
Free shipping on orders over $99 · 30-day returns
FREND PSA PLUS (reagent cartridge) is an FDA 510(k)-cleared medical device (K162378) manufactured by Nanoentek USA, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2017. Regulation: 8.