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510(k) K241741

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. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2024
Date Received
June 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Guangzhou Wondfo Biotech Co., Ltd.

  • K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C (November 18, 2025)
  • K251289 — WELLlife COVID-19 Antigen Test Rx (October 22, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Pan (September 25, 2020)
  • K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup (December 3, 2018)
  • K173229 — Preview Digital Pregnancy Test (March 12, 2018)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)
  • K152495 — Wondfo Propoxyphene Urine Test (November 23, 2015)
  • K150022 — Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregna (August 7, 2015)

Other clearances for product code NGL

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  • K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (April 15, 2025)
  • K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (February 20, 2025)
  • K242428 — Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Doche (February 6, 2025)
  • K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Dru (December 17, 2024)
  • K243064 — ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfe (November 20, 2024)
  • K242802 — CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (November 8, 2024)
  • K241869 — BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSi (October 4, 2024)
  • K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl (August 14, 2024)
  • K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (May 22, 2024)