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FDA 510(k)

ST AIA-PACK BNP

K-Number: K192380 · 2020-08-24

ApplicantFujirebio Diagnostics,Inc.
Decision Date2020-08-24
Product CodeNBC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ST AIA-PACK BNP is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-08-24 under approval number K192380. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST AIA-PACK BNP?

ST AIA-PACK BNP is a medical device that received FDA 510(k) clearance on 2020-08-24. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K192380.

When was ST AIA-PACK BNP approved by the FDA?

ST AIA-PACK BNP received FDA 510(k) clearance on 2020-08-24, under approval number K192380.

What company makes ST AIA-PACK BNP?

ST AIA-PACK BNP is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for ST AIA-PACK BNP?

The FDA product code for ST AIA-PACK BNP is NBC.

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Related Devices (Code: NBC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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