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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 K191099
Device Name Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
Applicant
Atlas Medical
King Abdullah Industrial Estate, Sahab free zone Area
P.O Box 204
Amman,  JO
Applicant Contact Amani AL-Habahbeh
Correspondent
Atlas Medical
King Abdullah Industrial Estate, Sahab free zone Area
P.O Box 204
Amman,  JO
Correspondent Contact Amani AL-Habahbeh
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DNK   JXM   JXN   LCM   LDJ   LFG  
Date Received04/25/2019
Decision Date 10/03/2019
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
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