TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 is an FDA 510(k)-cleared medical device (K033383) manufactured by Biosite Incorporated. 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 December 22, 2003. Regulation: 8.