VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE

VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE is an FDA 510(k)-cleared medical device (K063492) manufactured by bioMerieux, 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 December 20, 2006. Regulation: 8.