• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 < 
 34 
 35 
 36 
 37 
 38 
 39 
 40 
 41 
 42 
 43 
 > 
 
500 records meeting your search criteria returned . please narrow your search.
New Searchexport reports to excelExport to Excel | helpHelp
Test Name
Document Test Type Effective Date
Wondfo USA Co. Ltd., WELLlife Flu A&B Home Test  (Anterior Nasal Swab)
K251563 Influenza A/B 08/21/2025
Wondfo USA Co, Ltd., Wondfo® PdG Urine Test  
CR240206 Pregnanediol Glucuronide 05/14/2024
Wondfo USA Co, Ltd., Wondfo HCG Early Result Pregnancy Test (Midstream)  
K150022 Urine hCG by visual color comparison tests 05/01/2025
Wondfo USA Co, Ltd., WELLlife iFOB Immunochemical Fecal Occult Blood Test  
K162333 Fecal occult blood 08/01/2024
Wondfo USA Co, Ltd., SAFElife™ T-Dip Nortriptyline (TCA) Urine Test Panel  
K202567 Nortriptyline 12/15/2023
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup  
K182701 Oxycodone 01/03/2025
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup  
K182701 Amphetamines 01/03/2025
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup  
K182701 Barbiturates 01/03/2025
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup  
K182701 Benzodiazepines 01/03/2025
Wondfo USA Co, Ltd., SAFElife™ S-Cup Multi-Drug Urine Test Cup  
K182701 Phencyclidine (PCP) 01/03/2025
-
-