Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is an FDA 510(k)-cleared medical device (K201256) manufactured by Procise Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2022. Regulation: 8.