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

FDA 510(k) Premarket Notification · Submission K241741 · Applicant: Guangzhou Wondfo Biotech Co., Ltd.

Public Record 510(k) Submission Decision Date: 2024-07-16 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K241741.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K241741
Device Name
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
Product Code
NGL
Decision Date
2024-07-16
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Clinical Toxicology (TX)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2024-06-17

Related Establishments / Registrations

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