510(k) K242428— Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

Substantially Equivalent

Guangzhou Decheng Biotechnology Co., Ltd.

Clearance details

Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
Product code: Code NGL
Advisory panel: Clinical Toxicology
Date received: 2024-08-15
Decision date: 2025-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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