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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, Amphetamine
510(k) Number K181945
Device Name QuickScreen Pro Multi Drug Screening Test, Model 9395Z
Applicant
Phamatech, Inc.
15175 Innovation Dr.
San Diego,  CA  92128
Applicant Contact Robert Merlock
Correspondent
Kara & Associates
6965 El Camino Real,
Suite 105-428
Carlsbad,  CA  92009
Correspondent Contact Korina A. Akhondzadeh
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   LCM   LDJ   LFG  
Date Received07/20/2018
Decision Date 10/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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