WILLCOGEN MENINGITIDIS KIT ZL25

WILLCOGEN MENINGITIDIS KIT ZL25 is an FDA 510(k)-cleared medical device (K851691) manufactured by Wellcome Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 1985. Regulation: 8.