LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 is an FDA 510(k)-cleared medical device (K992252) manufactured by Chemicon Intl., 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 August 9, 1999. Regulation: 8.