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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
Generic NameEnzyme immunoassay, cannabinoids
Regulation Number862.3870
ApplicantPERSONAL HEALTH & HYGIENE, INC.
2 NORTH CHARLES STREE
BALTIMORE, MD 21201
PMA NumberP950040
Supplement NumberS002
Date Received02/05/1997
Decision Date02/05/1997
Product Code LDJ 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: CHANGING THE TESTING LABORATORY TO AMERICAL MEDICAL LABORATORY (AML); INCLUDING HEROIN TESTING AS PART OF THE TEST SYSTEM; AND REVISED LABELING IN ASSOCIATION WITH THE ADDED HEROIN TESTING.
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