CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup— 510(k) K180255

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) clearance K180255 for CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup, Substantially Equivalent on 2018-02-28. Applicant: Hangzhou Clongene Biotech Co., Ltd..

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code PTH
Advisory panel: Clinical Toxicology
Date received: 2018-01-30
Decision date: 2018-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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