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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, Benzodiazepine
510(k) Number K190968
Device Name CEDIA Benzodiazepine Assay
Applicant
Microgenics Corporation
45600 Kato Rd.
Fremont,  CA  94538
Applicant Contact Minoti Patel
Correspondent
Microgenics Corporation
45600 Kato Rd.
Fremont,  CA  94538
Correspondent Contact Minoti Patel
Regulation Number862.3170
Classification Product Code
JXM  
Date Received04/12/2019
Decision Date 12/09/2019
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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