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 K003557
Device Name ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
Applicant
ACON Laboratories, Inc.
11175 Flintkote Ave., #F
San Diego,  CA  92121
Applicant Contact NORA C.R. YORK
Correspondent
ACON Laboratories, Inc.
11175 Flintkote Ave., #F
San Diego,  CA  92121
Correspondent Contact NORA C.R. YORK
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received11/17/2000
Decision Date 03/15/2001
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
-
-