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FDA 510(k)

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

K-Number: K161251 · 2016-08-30

ApplicantHangzhou Clongene Biotech Co., Ltd.
Decision Date2016-08-30
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-08-30 under 510(k) number K161251. 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 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests?

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests is a medical device that received FDA 510(k) clearance on 2016-08-30. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K161251.

When did CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests receive FDA 510(k) clearance?

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests received FDA 510(k) clearance on 2016-08-30, under 510(k) number K161251.

Who is the listed applicant for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests?

The FDA product code for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests is DKZ.

Other records listing Hangzhou Clongene Biotech Co., Ltd. as applicant

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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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