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

Premarket Approval (PMA)
  • 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
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDR. BROWN'S HOME DRUG TESTING KIT
Generic NameEnzyme immunoassay, cannabinoids
Regulation Number862.3870
ApplicantPERSONAL HEALTH & HYGIENE, INC.
2 NORTH CHARLES STREE
BALTIMORE, MD 21201
PMA NumberP950040
Date Received12/19/1995
Decision Date01/21/1997
Product Code LDJ 
Docket Number 97M-0257
Notice Date 06/30/1997
Advisory Committee Toxicology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DR. BROWN'S HOME DRUG TESTING SYSTEM. DR. BROWN'S HOME DRUG TESTING SYSTEM IS AN OVER-THE-COUNTER COLLECTION AND TRANSPORT SYSTEM INTENDED FOR USE BY INDIVIDUALS WISHING TO ANONYMOUSLY TEST URINE SAMPLES FOR DRUGS OF ABUSE (MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, PHYENCYCLIDINE (PCP), CODEINE, AND MORPHINE).
Supplements:  S001 S002 S003 
-
-