CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup— 510(k) K190412

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) clearance K190412 for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup, Substantially Equivalent on 2019-03-21. Applicant: Hangzhou Clongene Biotech Co., Ltd..

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code NGL
Advisory panel: Clinical Toxicology
Date received: 2019-02-21
Decision date: 2019-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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