Cleared Traditional

Alere NT-proBNP for Alinity i Reagent Kit

K241176 · Axis-Shield Diagnostics, Ltd. · Chemistry
Jan 2025
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K241176 is an FDA 510(k) clearance for the Alere NT-proBNP for Alinity i Reagent Kit, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on January 16, 2025, 262 days after receiving the submission on April 29, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K241176 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2024
Decision Date January 16, 2025
Days to Decision 262 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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