Cleared Traditional

Elecsys proBNP II, Elecsys proBNP II STAT

K223637 · Roche Diagnostics · Chemistry
Jul 2023
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K223637 is an FDA 510(k) clearance for the Elecsys proBNP II, Elecsys proBNP II STAT, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on July 21, 2023, 228 days after receiving the submission on December 5, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K223637 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2022
Decision Date July 21, 2023
Days to Decision 228 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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