Cleared Traditional

ST AIA-PACK BNP

K192380 · Fujirebio Diagnostics,Inc. · Chemistry
Aug 2020
Decision
360d
Days
Class 2
Risk

About This 510(k) Submission

K192380 is an FDA 510(k) clearance for the ST AIA-PACK BNP, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 24, 2020, 360 days after receiving the submission on August 30, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K192380 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2019
Decision Date August 24, 2020
Days to Decision 360 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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