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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK013778
Test Name ALATEX SCIENTIFIC PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST  
Manufacturer NameADVANTAGE DIAGNOSTICS CORP.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypePhencyclidine (PCP)
Effective Date02/21/2002
Device Classification Name kit, test, multiple, drugs of abuse, over the counter
510(k) Number K013778
Device Name PEACE OF MIND HOME DRUG TEST
Applicant
ADVANTAGE DIAGNOSTICS CORP.
1201 DOUGLAS AVE.
REDWOOD CITY,  CA  94063
Applicant Contact JANIS FREESTONE
Correspondent
ADVANTAGE DIAGNOSTICS CORP.
1201 DOUGLAS AVE.
REDWOOD CITY,  CA  94063
Correspondent Contact JANIS FREESTONE
Classification Product Code
MVO  
Subsequent Product Codes
DJC   LDJ  
Date Received11/13/2001
Decision Date 02/07/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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