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Document NumberK163704
Test Name Xiamen USEFUL Imp And Exp CO., LTD, Diagnostic Test One Step Rapid Test DipCard  
Manufacturer NameHEALGEN SCIENTIFIC LLC
Consumer Information Phone Number(800)986-2092
Test TypeMethadone
Effective Date07/11/2019
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 East 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
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