FDA 510(k)

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

Numéro K : K161251 · 2016-08-30

DemandeurHangzhou Clongene Biotech Co., Ltd.

Date de décision2016-08-30

Code produitDKZ

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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