ST Aia-Pack BNP

FDA 510(k) K192380 · Fujirebio Diagnostics,Inc.

Substantially Equivalent

510(k) numberK192380

Submission

Device name
ST Aia-Pack BNP
Applicant
Fujirebio Diagnostics,Inc.
Malvern, PA, US
Received
August 30, 2019
Decision date
August 24, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBC – Test, Natriuretic Peptide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1117
Specialty
Clinical Chemistry

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Questions and answers

When was ST Aia-Pack BNP cleared by the FDA?

ST Aia-Pack BNP (K192380) received a 510(k) decision of Substantially Equivalent on August 24, 2020, 360 days after the submission was received.

What is the product code of K192380?

The FDA product code is NBC – Test, Natriuretic Peptide, a Class II (moderate risk) device regulated under 21 CFR 862.1117.