ARCHITECT BNP ASSAY, MODEL 8K28

ARCHITECT BNP ASSAY, MODEL 8K28 is an FDA 510(k)-cleared medical device (K060964) manufactured by Fujirebio Diagnostics,Inc.. 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 May 24, 2006. Regulation: 8.