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OTC - Over The Counter
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Document NumberK151642
Test Name Healgen Scientific LLC, Invitro Pro® Multi-Drug Urine Test Cup  
Manufacturer NameHEALGEN SCIENTIFIC LLC
Consumer Information Phone Number1(866)982-3818
Test TypeCannabinoids (THC)
Effective Date12/15/2015
Device Classification Name enzyme immunoassay, benzodiazepine
510(k) Number K151642
Device Name Heagen 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  
LAF   LCM   LDJ  
Date Received06/18/2015
Decision Date 08/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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