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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(k) Number K213211
Device Name Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
Applicant
Carolina Liquid Chemistries Corp.
313 Gallimore Dairy Rd.
Greensboro,  NC  27409
Applicant Contact Patricia A Shugart
Correspondent
Carolina Liquid Chemistries Corp.
313 Gallimore Dairy Rd.
Greensboro,  NC  27409
Correspondent Contact Philip G Shugart
Regulation Number862.3250
Classification Product Code
DIO  
Date Received09/29/2021
Decision Date 01/27/2022
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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