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 NumberK160793
Test Name Express Diagnostics International, Inc., DrugCheck NxStep OnSite EDDP Drug Test Cup  
Manufacturer NameW.H.P.M., INC.
Consumer Information Phone Number1(888)466-8433
Test TypeMethadone metabolite (EDDP)
Effective Date07/02/2019
Device Classification Name enzyme immunoassay, methadone
510(k) Number K160793
Device Name First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
Applicant
W.H.P.M., INC.
5358 IRWINDALE AVE.
IRWINDALE,  CA  91706
Applicant Contact John Wan
Correspondent
LSI Consulting
504 East Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3620
Classification Product Code
DJR  
Subsequent Product Codes
LAF   LFG  
Date Received03/23/2016
Decision Date 08/17/2016
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
-
-