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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 the device name listed in this FDA 510(k) record. The listed applicant is Xenta Biomedical Science Co., Ltd.. It received FDA 510(k) clearance on 2023-05-19 under 510(k) 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. The listed applicant is Xenta Biomedical Science Co., Ltd.. The 510(k) number is K231137.

When did Xenta Drug Screen Cup, Xenta Drug Screen Dipcard receive FDA 510(k) clearance?

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

Who is the listed applicant for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

The FDA 510(k) record lists Xenta Biomedical Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Xenta Biomedical Science Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222955Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

Related Devices (Code: DKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.

Official Source

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

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