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FDA 510(k)

Advin Multi-Drug Screen Test Cassette, Dip Card and Cup

K-Number: K122809 · 2013-06-17

ApplicantAdvin Biotech
Decision Date2013-06-17
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Advin Multi-Drug Screen Test Cassette, Dip Card and Cup is the device name listed in this FDA 510(k) record. The listed applicant is Advin Biotech. It received FDA 510(k) clearance on 2013-06-17 under 510(k) number K122809. 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 Advin Multi-Drug Screen Test Cassette, Dip Card and Cup?

Advin Multi-Drug Screen Test Cassette, Dip Card and Cup is a medical device that received FDA 510(k) clearance on 2013-06-17. The listed applicant is Advin Biotech. The 510(k) number is K122809.

When did Advin Multi-Drug Screen Test Cassette, Dip Card and Cup receive FDA 510(k) clearance?

Advin Multi-Drug Screen Test Cassette, Dip Card and Cup received FDA 510(k) clearance on 2013-06-17, under 510(k) number K122809.

Who is the listed applicant for Advin Multi-Drug Screen Test Cassette, Dip Card and Cup?

The FDA 510(k) record lists Advin Biotech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advin Multi-Drug Screen Test Cassette, Dip Card and Cup?

The FDA product code for Advin Multi-Drug Screen Test Cassette, Dip Card and Cup is DKZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science 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.

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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