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FDA 510(k)

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

K-Number: K231137 · 2023-05-19

ApplicantXenta Biomedical Science Co., Ltd.
Decision Date2023-05-19
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is a medical device manufactured by Xenta Biomedical Science Co., Ltd.. It received FDA 510(k) clearance on 2023-05-19 under approval number K231137. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Xenta Biomedical Science Co., Ltd.. The 510(k) number is K231137.

When was Xenta Drug Screen Cup, Xenta Drug Screen Dipcard approved by the FDA?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard received FDA 510(k) clearance on 2023-05-19, under approval number K231137.

What company makes Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is manufactured by Xenta Biomedical Science Co., Ltd..

What is the FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

The FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is DKZ.

Other Devices by Xenta Biomedical Science Co., Ltd.

K222955Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

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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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