CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE

CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE is an FDA 510(k)-cleared medical device (K872795) manufactured by Medex, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1987. Regulation: 8.