510(k) K052789

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

K052789 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200". The FDA issued a decision of Substantially Equivalent on January 23, 2006. 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.