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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, cannabinoids
510(k) Number K192515
Device Name BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
Applicant
Shenzhen Bioeasy Biotechnology Co.,Ltd.
No.2-1, Liuxian 1st Road, Xin'an Sub-District
Shenzhen,  CN 518101
Applicant Contact Wenhau Yan
Correspondent
LSI International Inc.
504E Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received09/13/2019
Decision Date 10/11/2019
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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