Cleared Traditional

ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

K051265 · Bayer Healthcare, LLC · Chemistry
Jun 2005
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K051265 is an FDA 510(k) clearance for the ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on June 13, 2005, 28 days after receiving the submission on May 16, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K051265 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2005
Decision Date June 13, 2005
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBC — Test, Natriuretic Peptide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1117

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