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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 K152590
Device Name ACCU NEWS Drug Screening Test Card/Urine Cup
Applicant
Coretests, Inc.
6190 Yarrow Dr.
Carlsbad,  CA  92011
Applicant Contact ERIC SUN
Correspondent
Coretests, Inc.
6190 Yarrow Dr.
Carlsbad,  CA  92011
Correspondent Contact ERIC SUN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DJG   LDJ  
Date Received09/10/2015
Decision Date 04/15/2016
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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