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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 K211973
Device Name DRI Cocaine Metabolite Assay
Applicant
Microgenics Corporation
46500 Kato Rd.
Fremond,  CA  94538
Applicant Contact Nikhita Tandon
Correspondent
Microgenics Corporation
46500 Kato Rd.
Fremond,  CA  94538
Correspondent Contact Nikhita Tandon
Regulation Number862.3250
Classification Product Code
DIO  
Date Received06/25/2021
Decision Date 09/24/2021
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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