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 NumberK050936
Test Name Acon Laboratories, Inc. On Call Home Drug Test for Marijuana and Cocaine  
Manufacturer NameACON LABORATORIES, INC.
Consumer Information Phone Number(800)825-9957
Test TypeCannabinoids (THC)
Effective Date06/30/2005
Device Classification Name enzyme immunoassay, cannabinoids
510(k) Number K050936
Device Name ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
Applicant
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
ACON LABORATORIES, INC.
4108 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD TUNG
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Code
DIO  
Date Received04/14/2005
Decision Date 06/24/2005
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
-
-