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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDR. BROWN'S HOME DRUG TESTING KIT
Classification Nameenzyme immunoassay, cannabinoids
Generic Nameenzyme immunoassay, cannabinoids
Regulation Number862.3870
Applicant
PERSONAL HEALTH & HYGIENE, INC.
2 north charles stree
baltimore, MD 21201
PMA NumberP950040
Supplement NumberS001
Date Received01/30/1997
Decision Date02/26/1997
Product Code
LDJ[ Registered Establishments with LDJ ]
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A VOLUNTARY PLEDGE AND CONSENT FORM AS PART OF THE LABELING
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