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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 K152643
Device Name EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
Applicant
Nantong Egens Biotech Co., Ltd.
Bldg. 15,1692 Xinghu Ave.
Nantong,  CN 226010
Applicant Contact Yan Cao
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Code
LAF  
Date Received09/15/2015
Decision Date 11/02/2015
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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