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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(k) Number K994219
Device Name AT HOME DRUG TEST, MODEL 9073
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
Regulation Number862.3250
Classification Product Code
DIO  
Date Received12/15/1999
Decision Date 12/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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