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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 K181499
Device Name DRI Cocaine Metabolite Assay
Applicant
Microgenics Corporation
46500 Kato Rd.
Fremont,  CA  94538
Applicant Contact Emily Chien
Correspondent
Microgenics Corporation
46500 Kato Rd.
Fremont,  CA  94538
Correspondent Contact Emily Chien
Regulation Number862.3250
Classification Product Code
DIO  
Date Received06/07/2018
Decision Date 07/06/2018
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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