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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, Phencyclidine
510(k) Number K994236
Device Name AT HOME DRUG TEST, MODEL 9133
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
LCM  
Date Received12/16/1999
Decision Date 12/30/1999
Decision Substantially Equivalent (SESE)
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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