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OTC - Over The Counter
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Document NumberK232736
Test Name Premier Biotech, LLC., Multi-Panel Drug Screen Dip Card Tests  
Manufacturer NameChemtron Biotech, Inc.
Consumer Information Phone Number1(888)686-9909
Test TypeTricyclic antidepressants
Effective Date03/21/2024
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K232736
Device Name Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
Applicant
Chemtron Biotech, Inc.
9245 Brown Deer Rd.
Suite B
San Diego,  CA  92121
Applicant Contact Jane Zhang
Correspondent
Chemtron Biotech, Inc.
9245 Brown Deer Rd.
Suite B
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   JXN   LAF   LCM   LDJ  
LFG  
Date Received09/07/2023
Decision Date 12/20/2023
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
Predetermined Change
Control Plan Authorized		 No
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