MICROSCAN MICROSTREP PLUS, MODEL B1027-201

MICROSCAN MICROSTREP PLUS, MODEL B1027-201 is an FDA 510(k)-cleared medical device (K091949) 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 January 25, 2010. Regulation: 8.