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 K000273
Device Name SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
Applicant
Drug Detection Devices, Ltd.
6820 Meadowridge Ct.
Suite A-7
Alpharetta,  GA  30005
Applicant Contact PATRICK BEENTJES
Correspondent
Drug Detection Devices, Ltd.
6820 Meadowridge Ct.
Suite A-7
Alpharetta,  GA  30005
Correspondent Contact PATRICK BEENTJES
Regulation Number862.3650
Classification Product Code
DJG  
Date Received01/28/2000
Decision Date 04/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-