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, Cannabinoids
510(k) Number K041221
Device Name ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
Applicant
Accu-Stat Diagnostics, Inc.
11 Orchard Rd., Suite 108
Lake Forest,  CA  92630
Applicant Contact JAMES G BARRONS
Correspondent
Accu-Stat Diagnostics, Inc.
11 Orchard Rd., Suite 108
Lake Forest,  CA  92630
Correspondent Contact JAMES G BARRONS
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DJG   DKZ   LAF   LCM  
MVO  
Date Received05/10/2004
Decision Date 07/13/2004
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
Predetermined Change
Control Plan Authorized		 No
-
-