CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests— 510(k) K161251

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) clearance K161251 for CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests, Substantially Equivalent on 2016-08-30. Applicant: Hangzhou Clongene Biotech Co., Ltd..

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code DKZ
Advisory panel: Clinical Toxicology
Date received: 2016-05-03
Decision date: 2016-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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