Cleared Traditional

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

K201312 · Ortho-Clinical Diagnostics · Chemistry
Oct 2021
Decision
504d
Days
Class 2
Risk

About This 510(k) Submission

K201312 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 4, 2021, 504 days after receiving the submission on May 18, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K201312 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2020
Decision Date October 04, 2021
Days to Decision 504 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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