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OTC - Over The Counter
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Document NumberK142408
Test Name Polymed Therapeutics FaStep Methamphetamine Panel Dip  
Manufacturer NamePOLYMED THERAPEUTICS, INC
Consumer Information Phone Number1(713)777-7088
Test TypeMethamphetamines
Effective Date09/26/2014
Device Classification Name enzyme immunoassay, cannabinoids
510(k) Number K142408
Device Name FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Applicant
POLYMED THERAPEUTICS, INC
3040 POST OAK BLVD, SUITE 1110
HOUSTON,  TX  77056
Applicant Contact FRANK LUO
Correspondent
LSI INTERNATIONAL
504 E DIAMOND AVE
STE.I
GAITHERSBURG,  MD  20877
Correspondent Contact JOE SHIA
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Code
LAF  
Date Received08/28/2014
Decision Date 09/25/2014
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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