Class Class II

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 (K241741)

K241741 2024-07-16 Traditional
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Description

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 by Guangzhou Wondfo Biotech Co., Ltd. — FDA 510(k) cleared clinical toxicology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241741
Clearance Date2024-07-16
Clearance TypeTraditional
Product CodeNGL
Regulation Number862.3650

Categories

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