SAFElife Fentanyl Urine Home Test (Cassette) +3 more— 510(k) K241741

Clearance details

Device name as filed

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

Applicant

Guangzhou Wondfo Biotech Co., Ltd.

Product code

Code NGL

Device class

Class 2

Regulation

21 CFR 862.3650

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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