LEGIONELLA IGG/IGM ELISA TEST SYSTEM

LEGIONELLA IGG/IGM ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K963318) manufactured by Armkel, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 2, 1997. Regulation: 8.