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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Morphine
510(k) Number K151557
Device Name EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
Applicant
Nantong Egens Biotech Co., Ltd.
Bldg. 15,1692 Xinghu Ave.
Nantong,  CN 226010
Applicant Contact BEN CHEN
Correspondent
LSI International, Inc.
504 E. Diamond Ave. Suite I
Gaithersburg,  MD  20878
Correspondent Contact JOE SHIA
Regulation Number862.3640
Classification Product Code
DNK  
Subsequent Product Code
LAF  
Date Received06/10/2015
Decision Date 07/16/2015
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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