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Data / Medical devices / United States / Wondfo Usa Co., Ltd.

Wondfo Usa Co., Ltd.: FDA-registered device maker in Bolingbrook, IL, United States, 18 510(k) clearances

Wondfo Usa Co., Ltd. is registered with the FDA (registration 3007606081) in Bolingbrook, IL, United States. It lists 44 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 28, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Wondfo Usa Co., Ltd.
FDA registration number
3007606081
Address
890 Remington Blvd, Bolingbrook, IL, United States, 60440
Owner or operator
Wondfo USA Co., Ltd. (10028951)
Roles
Complaint file establishment
First device listed
May 29, 2009
Registered through
2027
Brand names listed
2SAN Home Drug Test Kit, 2San™ COVID-19 Rapid Self-Test, 2San™ Colorectal Health Test (immunochemical fecal occult blood test), Areta Multi-Drug Test Cup, Areta Multi-Drug Test Cup, ACDOA-1144, Areta Multi-Drug Test Cup, ACDOA-264, Areta Multi-Drug Test Cup, ACDOA-6125B, Areta Multi-Drug Test Cup, ACDOA-754 and more

Devices it lists

DeviceProduct codeClassRoleSource
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Complaint file establishmentaccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Complaint file establishmentaccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Complaint file establishmentaccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Complaint file establishmentaccessdata.fda.gov
Covid-19 Multi-Analyte Antigen DeviceQMNNComplaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Complaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUComplaint file establishmentaccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Complaint file establishmentaccessdata.fda.gov
Fluorometer, For Clinical UseKHO1Complaint file establishmentaccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Complaint file establishmentaccessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The CounterQKE1Complaint file establishmentaccessdata.fda.gov
Kit, Direct Antigen, Positive ControlMJZ1Complaint file establishmentaccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Complaint file establishmentaccessdata.fda.gov
Over-The-Counter Covid-19 Antigen TestQYT2Complaint file establishmentaccessdata.fda.gov
Reagent, Occult BloodKHE2Complaint file establishmentaccessdata.fda.gov
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient SettingsQVF2Complaint file establishmentaccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Complaint file establishmentaccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Complaint file establishmentaccessdata.fda.gov
Test, Amphetamine, Employment And Insurance Testing, ExemptPUX2Complaint file establishmentaccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Complaint file establishmentaccessdata.fda.gov
Test, Barbiturate, Employment And Insurance Testing, ExemptPUY2Complaint file establishmentaccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Complaint file establishmentaccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Complaint file establishmentaccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Complaint file establishmentaccessdata.fda.gov
Test, Cannabinoid, Employment And Insurance Testing, ExemptPVJ2Complaint file establishmentaccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Complaint file establishmentaccessdata.fda.gov
Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptPVA2Complaint file establishmentaccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Complaint file establishmentaccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Complaint file establishmentaccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Complaint file establishmentaccessdata.fda.gov
Test, Methadone, Employment And Insurance Testing, ExemptPVE2Complaint file establishmentaccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Complaint file establishmentaccessdata.fda.gov
Test, Methamphetamine, Employment And Insurance Testing, ExemptPVD2Complaint file establishmentaccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Complaint file establishmentaccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Complaint file establishmentaccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Complaint file establishmentaccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Complaint file establishmentaccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Complaint file establishmentaccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 28, 2026K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
November 18, 2025K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
October 22, 2025K251289WELLlife COVID-19 Antigen Test RxQVFSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
September 30, 2024K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
July 16, 2024K241741SAFElife™ 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 PanelNGLSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
December 13, 2022K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11DJGSubstantially EquivalentShenzhen Superbio Technology Co., Ltd.accessdata.fda.gov
September 25, 2020K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
December 3, 2018K182701Wondfo T-Cup Multi-Drug Urine Test CupNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
May 14, 2017K162333Wondfo One Step Fecal Occult Blood (FOB) TestKHESubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
August 7, 2015K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test MidstreamLCXSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
February 25, 2014K133968WONDFO MULTI-DRUG URINE TEST CUP, PANELDKZSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
January 31, 2014K133343WONDFO RAPID STREP A TESTGTYSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
April 9, 2013K130665WONDOFO MULTI-DRUG URINE TEST CUP / PANELDJGSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
July 25, 2012K121557WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TESTLDJSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
October 4, 2011K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTDICSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
May 20, 2011K110182CANNABINOIDS URINE TESTLDJSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
April 21, 2009K072500ONE STEP HCG URINE/SERUM TESTDHASubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
April 8, 2005K043443ONE STEP HCG URINE PREGNANCY TESTLCXSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
April 22, 202494261Class IIOngoingPreview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.accessdata.fda.gov

Compare with other makers

Updated April 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.