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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 K173303
Device Name INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
Applicant
Alfa Scientific Designs, Inc.
13200 Gregg St.
Powat,  CA  92064
Applicant Contact Naishu Wang
Correspondent
Alfa Scientific Designs, Inc.
13200 Gregg St.
Powat,  CA  92064
Correspondent Contact Naishu Wang
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DNK   JXM   LCM   LDJ   LFG   NFT  
NFV   NFW   NFY   NGG   NGI   NGL  
NGM   PTG   PTH   QAW  
Date Received10/18/2017
Decision Date 02/23/2018
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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