Guangzhou Wondfo Biotech Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 42
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2788-2018 | Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40 | May 18, 2018 |
| Z-2787-2018 | Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usa | May 18, 2018 |
| Z-2789-2018 | Class II | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OP | May 18, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | 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 |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElif | July 16, 2024 |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | 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 COC 150(Cup, Dipcard | 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 Pregnancy Test Cassette, W | August 7, 2015 |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | July 1, 2015 |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | April 7, 2015 |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | February 25, 2015 |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | January 13, 2015 |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | December 18, 2014 |
| K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | August 25, 2014 |
| K141532 | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE | July 14, 2014 |
| K140089 | CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) | April 8, 2014 |
| K133968 | WONDFO MULTI-DRUG URINE TEST CUP, PANEL | February 25, 2014 |