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

510(k) Premarket Notification
  • 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
Device Classification Name enzyme immunoassay, opiates
510(k) Number K222955
Device Name Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Applicant
Xenta Biomedical Science Co., Ltd.
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue,
Huangpu District
Guangzhou,  CN 510535
Applicant Contact Huang Ling
Correspondent
Xenta Biomedical Science Co., Ltd.
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue,
Huangpu District
Guangzhou,  CN 510535
Correspondent Contact Huang Ling
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DJC   LDJ  
Date Received09/27/2022
Decision Date 02/06/2023
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
-
-