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Document NumberK142396
Test Name Clarity Diagnostics Multi-Panel Drug Screen Dip Card Tests  
Manufacturer NameChemtron Biotech, Inc.
Consumer Information Phone Number(888)881-6788
Test TypeOxycodone
Effective Date12/29/2014
Device Classification Name enzyme immunoassay, opiates
510(k) Number K142396
Device Name Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
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 Code
LGF  
Date Received08/27/2014
Decision Date 10/09/2014
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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