WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 is an FDA 510(k)-cleared medical device (K854851) 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 February 3, 1986. Regulation: 8.