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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDR. BROWN'S HOME DRUG TESTING KIT
Classification Nameenzyme immunoassay, cannabinoids
Generic Namespecimen collection kit
Regulation Number862.3870
ApplicantPERSONAL HEALTH & HYGIENE, INC.
PMA NumberP950040
Supplement NumberS002
Date Received02/05/1997
Decision Date02/05/1997
Product Code
LDJ[ Registered Establishments with LDJ ]
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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