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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, opiates
510(k) Number K231007
Device Name CEDIA Heroin Metabolite (6-AM) Assay
Applicant
Microgenics Corporation
46500 Kato Road
Fremont,  CA  94538
Applicant Contact Amrit Takhar
Correspondent
Microgenics Corporation
46500 Kato Road
Fremont,  CA  94538
Correspondent Contact Amrit Takhar
Regulation Number862.3650
Classification Product Code
DJG  
Date Received04/07/2023
Decision Date 09/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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