CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM

CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM is an FDA 510(k)-cleared medical device (K780526) manufactured by I M, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 1978. Regulation: 8.