Cleared Traditional

ADVIA Centaur? NT-proBNPII (PBNPII)

K220265 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Sep 2023
Decision
601d
Days
Class 2
Risk

About This 510(k) Submission

K220265 is an FDA 510(k) clearance for the ADVIA Centaur? NT-proBNPII (PBNPII), a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on September 24, 2023, 601 days after receiving the submission on January 31, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K220265 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2022
Decision Date September 24, 2023
Days to Decision 601 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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