510(k) K072437

ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET by Roche Diagnostics — Product Code NBC

K072437 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET". The FDA issued a decision of Substantially Equivalent on February 5, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Roche Diagnostics has at least 10 other 510(k) clearances on record.