SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx— 510(k) K260065
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K260065 for SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx, Substantially Equivalent on 2026-04-28. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Summary
Guangzhou Wondfo Biotech's record names two products: the SAFElife T-Dip Multi-Drug Urine Test Panel and the SAFElife T-Dip Multi-Drug Urine Test Panel Dx. Both are filed under product code NFT (Test, Amphetamine, Over The Counter), and the record doesn't say how the two differ.
Class II, 21 CFR 862.3100. It came in as a Traditional 510(k), and Clinical Toxicology is both the classification panel and the review panel.
Guangzhou Wondfo Biotech filed from Guangzhou, China. Review took 109 calendar days (January 9 to April 28, 2026).
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Product code NFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code NFT
view all- K261409 — BioTeke® Multi-Drug Urine Test Cup
- K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
More clearances from Guangzhou Wondfo Biotech Co., Ltd.
view all- K251289 — WELLlife COVID-19 Antigen Test Rx
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
- K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
- K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup
Data sourced from openFDA. This site is unofficial and independent of the FDA.