Cleared Traditional

Access NT-proBNP

K232164 · Beckman Coulter, Inc. · Chemistry
Apr 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K232164 is an FDA 510(k) clearance for the Access NT-proBNP, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on April 12, 2024, 266 days after receiving the submission on July 21, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K232164 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2023
Decision Date April 12, 2024
Days to Decision 266 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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