PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT is an FDA 510(k)-cleared medical device (K020823) manufactured by Sanquin Blood Supply Foundation. 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 13, 2002. Regulation: 8.