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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, test, multiple, drugs of abuse, over the counter
510(k) Number K992217
Device Name AT HOME DRUG TEST, MODEL 9175
Applicant
PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO,  CA  92126
Applicant Contact CARL A MONGIOVI
Correspondent
PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO,  CA  92126
Correspondent Contact CARL A MONGIOVI
Classification Product Code
MVO  
Subsequent Product Codes
DJC   DJG   LDJ  
Date Received07/01/1999
Decision Date 07/13/1999
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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