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OTC - Over the Counter

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IVD Over the Counter (OTC) record K143599 and corresponding
510(K) Premarket Notification information

Test NameNative Diagnostics International; DrugSmart Drug Screen Cup Tests with OPI 2000  
Manufacturer NameChemtron Biotech, Inc.
Consumer Information Phone Number(760)494-7502
IVD Document NumberK143599
Test TypeOpiates
Effective Date06/03/2015
Device Classification Name enzyme immunoassay, opiates
510(k) Number K143599
Device Name Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
Applicant
Chemtron Biotech, Inc.
9245 Brown Deer Road
san diego,  CA  92121
Applicant Contact jane zhang
Correspondent
Chemtron Biotech, Inc.
9245 Brown Deer Road
san diego,  CA  92121
Correspondent Contact jane zhang
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DKZ  
DNK   JXM   LAF   LCM   LDJ   LFG  
Date Received12/18/2014
Decision Date 04/17/2015
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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