
Wako Chemicals USA, Inc.
Free shipping on orders over $99 · 30-day returns
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS is an FDA 510(k)-cleared medical device (DEN050002) manufactured by Wako Chemicals 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 18, 2005. Regulation: 8.