
Inova Diagnostics, Inc.
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QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 is an FDA 510(k)-cleared medical device (K143754) manufactured by Inova Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2015. Regulation: 8.