I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)

I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) is an FDA 510(k)-cleared medical device (K053597) manufactured by I-Stat Corporation. 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 July 20, 2006. Regulation: 8.