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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 K010655
Device Name AT HOME DRUG TESTT, MODEL 9150 T
Applicant
PHAMATECH
9530 PADGETT ST. #101
SAN DIEGO,  CA  92126
Applicant Contact CARL A MONGIOVI
Correspondent
PHAMATECH
9530 PADGETT ST. #101
SAN DIEGO,  CA  92126
Correspondent Contact CARL A MONGIOVI
Classification Product Code
MVO  
Date Received03/05/2001
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
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