FDA 510(k)

CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

N.º K: K161251 · 2016-08-30

SolicitanteHangzhou Clongene Biotech Co., Ltd.

Fecha de decisión2016-08-30

Código de productoDKZ

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

Ver en la base de datos de la FDA →

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