Cleared Traditional

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

K043228 · Bayer Healthcare, LLC · Chemistry
Apr 2005
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K043228 is an FDA 510(k) clearance for the ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS, 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 April 22, 2005, 151 days after receiving the submission on November 22, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K043228 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2004
Decision Date April 22, 2005
Days to Decision 151 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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