
Roche Diagnostics
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ACCU-CHEK Performa Blood Glucose Monitoring System is an FDA 510(k)-cleared medical device (K133741) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2014. Regulation: 8.