Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
 

New Search Back to Search Results
Document NumberK182701
Test Name Easy Healthcare Corporation Areta Multi-Drug Test Cup  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(855)822-6999
Test TypeAmphetamines
Effective Date10/13/2021
Device Classification Name test, amphetamine, over the counter
510(k) Number K182701
Device Name Wondfo T-Cup Multi-Drug Urine Test Cup
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City
Guangzhou,  CN 510641
Applicant Contact Bin Chen
Correspondent
LSI International
504 E Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
LCM   NFV   NFW   NFY   NGG  
NGL   PTG   PTH   QAW   QBF  
Date Received09/27/2018
Decision Date 12/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-