510(k) K242802— CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code NGL
Advisory panel: Clinical Toxicology
Date received: 2024-09-17
Decision date: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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