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Document NumberK153597
Test Name Clinical Reference Laboratory, CRLStat Multi-Drug Urine Test Dip Card  
Manufacturer NameHEALGEN SCIENTIFIC LLC
Consumer Information Phone Number1(800)445-9617
Test TypePhencyclidine (PCP)
Effective Date05/03/2021
Device Classification Name enzyme immunoassay, benzodiazepine
510(k) Number K153597
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 XIA
Regulation Number862.3170
Classification Product Code
JXM  
Subsequent Product Codes
DIO   DIS   DJG   DJR   DKZ  
LAF   LCM   LDJ  
Date Received12/16/2015
Decision Date 05/23/2016
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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