CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test— 510(k) K153741

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) clearance K153741 for CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test, Substantially Equivalent on 2016-03-18. Applicant: Hangzhou Clongene Biotech Co., Ltd..

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code LDJ
Advisory panel: Clinical Toxicology
Date received: 2015-12-28
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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