Chrysalis Intelligence · Sponsors · Guangzhou Wondfo Biotech Co., Ltd.

Guangzhou Wondfo Biotech Co., Ltd.

Guangzhou, CN · 6 510(k) clearances

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Total clearances
6
2020-09-25 → 2026-04-28
Last 12 months
3
Product codes
4
Most recent
2026-04-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NFT Test, Amphetamine, Over The Counter Class II Clinical Toxicology 3 2026-04-28
QVF — — — 1 2025-10-22
QYT Over-The-Counter Covid-19 Antigen Test Class II Microbiology 1 2024-09-30
NGL Test, Opiates, Over The Counter Class II Clinical Toxicology 1 2024-07-16
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-04-28 K260065 SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx NFT Class II Clinical Toxicology
2025-11-18 K252550 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx NFT Class II Clinical Toxicology
2025-10-22 K251289 WELLlife COVID-19 Antigen Test Rx QVF — —
2024-09-30 K241317 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) QYT Class II Microbiology
2024-07-16 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 NGL Class II Clinical Toxicology
2020-09-25 K202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx NFT Class II Clinical Toxicology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence