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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 K022564
Device Name INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
Applicant
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Applicant Contact NAISHU WANG
Correspondent
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Correspondent Contact NAISHU WANG
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DOE  
DPK   JXM   LAF   LCM   LDJ  
Date Received08/02/2002
Decision Date 08/30/2002
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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