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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, Benzodiazepine
510(k) Number K163704
Device Name Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card
Applicant
Healgen Scientific,, LLC
5213 Maple St.
Bellaire,  TX  77401
Applicant Contact Jianqiu Fang
Correspondent
LSI International, Inc.
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3170
Classification Product Code
JXM  
Subsequent Product Codes
DIO   DIS   DJG   DJR   DKZ  
JXN   LAF   LCM   LDJ   LFG  
Date Received12/29/2016
Decision Date 08/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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