510(k) K082645

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 by Siemens Healthcare Diagnostics — Product Code NBC

K082645 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623". The FDA issued a decision of Substantially Equivalent on September 22, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.