ATI(R) DISP BIOLOGICAL-PLUS TEST PACK

ATI(R) DISP BIOLOGICAL-PLUS TEST PACK is an FDA 510(k)-cleared medical device (K925745) manufactured by Pymah Corp.. 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 January 31, 1994. Regulation: 8.