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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 K243498
Device Name Alinity c Benzodiazepines Reagent Kit
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 Number862.3170
Classification Product Code
JXM  
Date Received11/12/2024
Decision Date 12/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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