510(k) K080578

DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA by Siemens Healthcare Diagnostics, Inc. — Product Code NBC

K080578 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA". The FDA issued a decision of Substantially Equivalent on May 16, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.