PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01

PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 is an FDA 510(k)-cleared medical device (K991945) manufactured by Pharmacia & Upjohn Co.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 1999. Regulation: 8.