Cleared Traditional

Elecsys proBNP II, Elecsys proBNP II STAT

K210546 · Roche Diagnostics · Chemistry
Mar 2022
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K210546 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 March 31, 2022, 399 days after receiving the submission on February 25, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K210546 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2021
Decision Date March 31, 2022
Days to Decision 399 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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