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, cocaine and cocaine metabolites
510(k) Number K000350
Device Name SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
Applicant
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT
SUITE A-7
ALPHARETTA,  GA  30005
Applicant Contact PATRICK BEENTJES
Correspondent
DRUG DETECTION DEVICES, LTD.
6820 MEADOWRIDGE COURT
SUITE A-7
ALPHARETTA,  GA  30005
Correspondent Contact PATRICK BEENTJES
Regulation Number862.3250
Classification Product Code
DIO  
Date Received02/03/2000
Decision Date 04/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-