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SAFElife™ Fentanyl Urine Home Test (Cassette) +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241741

by Guangzhou Wondfo Biotech Co., Ltd.

Identifiers

510(k) Number
K241741 FDA 510(k)
FDA Product Code
NGL FDA 510(k)
Models / Variants
SAFElife™ Fentanyl Urine Home Test (Cassette) FDA 510(k)
SAFElife™ Fentanyl (FTY) Urine Test Cassette FDA 510(k)
SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) FDA 510(k)
SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3650 FDA 510(k)
Regulation Number
862.3650 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SAFElife™ Fentanyl Urine Home Test (Cassette) +3 more models by Guangzhou Wondfo Biotech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K241741 24 fields · synced Jun 18, 2026