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FDA 510(k)

Diacore

K-Number: K253926 · 2026-04-10

ApplicantShenB Co., Ltd.
Decision Date2026-04-10
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Diacore is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under approval number K253926. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diacore?

Diacore is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K253926.

When was Diacore approved by the FDA?

Diacore received FDA 510(k) clearance on 2026-04-10, under approval number K253926.

What company makes Diacore?

Diacore is manufactured by ShenB Co., Ltd..

What is the FDA product code for Diacore?

The FDA product code for Diacore is NGX.

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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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