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) | Registration & Listing | Adverse Events | Recalls | PMA | 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, cocaine and cocaine metabolites
510(K) Number K112071
Device Name WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
504 east diamond ave.
suite f
gaithersbrug,  MD  20878
Contact joe shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Code
LAF  
Date Received07/20/2011
Decision Date 09/23/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-