SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel— 510(k) K241741

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K241741 for SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel, Substantially Equivalent on 2024-07-16. Applicant: Guangzhou Wondfo Biotech Co., Ltd..

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code NGL
Advisory panel: Clinical Toxicology
Date received: 2024-06-17
Decision date: 2024-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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