510(k) K071767

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A by Dade Behring, Inc. — Product Code NBC

K071767 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A". The FDA issued a decision of Substantially Equivalent on August 4, 2007. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.