Cleared Special

ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190

K092649 · Roche Diagnostics Corp. · Chemistry

Feb 2010

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K092649 is an FDA 510(k) clearance for the ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on February 4, 2010, 160 days after receiving the submission on August 28, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number	K092649 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2009
Decision Date	February 04, 2010
Days to Decision	160 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF