MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 is an FDA 510(k)-cleared medical device (K091264) manufactured by Siemens Healthcare 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 July 21, 2009. Regulation: 8.