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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 K131645
Device Name INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
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  
JXM   LCM   LDJ   LFG  
Date Received06/05/2013
Decision Date 10/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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