510(k) K033383

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 by Biosite Incorporated — Product Code NBC

K033383 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200". The FDA issued a decision of Substantially Equivalent on December 23, 2003. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Biosite Incorporated has at least 10 other 510(k) clearances on record.