
Siemens Healthcare Diagnostics
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MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES is an FDA 510(k)-cleared medical device (K101425) 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 September 9, 2010. Regulation: 8.