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OTC - Over the Counter

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IVD Over the Counter (OTC) record K151348 and corresponding
510(K) Premarket Notification information

Test NameHealgen Scientific LLC, Healgen Propoxyphene Test Strip  
Manufacturer NameHEALGEN SCIENTIFIC LLC
Consumer Information Phone Number(866)982-3818
IVD Document NumberK151348
Test TypePropoxyphene
Effective Date08/24/2015
Device Classification Name radioimmunoassay, tricyclic antidepressant drugs
510(k) Number K151348
Device Name Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, 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 Number862.3910
Classification Product Code
LFG  
Subsequent Product Codes
DJR   JXN  
Date Received05/20/2015
Decision Date 08/18/2015
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
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