HUMAN, C-REACTIVE PROTEIN (CRP)

HUMAN, C-REACTIVE PROTEIN (CRP) is an FDA 510(k)-cleared medical device (K791650) manufactured by Beckman Instruments, 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 16, 1979. Regulation: 8.