510(k) K092649

ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 by Roche Diagnostics Corp. — Product Code NBC

K092649 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190". The FDA issued a decision of Substantially Equivalent on February 4, 2010. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.